Pancreatic Cancer
Conditions
Keywords
Radiotherapy, Radiation, SBRT
Brief summary
An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.
Interventions
DEVICETraceIT Tissue Spacer implantation
The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines 3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement. 4. Subject is able to comply with motion management guidelines. 5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated. 6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration. 7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: 1. White blood cell count: ≥ 3.0 x 109/L 2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L 3. Platelets: ≥ 100 x 109/L 4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN) 5. AST and ALT: ≤ 3.0 times institutional upper normal limit 6. Serum creatinine: \< 1.5 times ULN e 7. INR: \< 1.5 8. Serum pregnancy: Negative 9. Hemoglobin: ≥ 8.0 g/dl 8. Zubrod Performance Status 0-2 9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site. 10. Life expectancy of at least 9 months
Exclusion criteria
1. Patients for whom radiotherapy is contraindicated 2. Previous thoracic or abdominal radiotherapy 3. Any GI abnormality that would interfere with the ability to access the injection site 4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy 5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening 6. Active gastroduodenal ulcer or uncontrolled watery diarrhea 7. History of Chronic Renal Failure. 8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia) 9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study. 10. Unable to comply with the study requirements or follow-up schedule. 11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject. 12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 2-6 week assessment post-procedure | Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month | The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | 18 months post procedure | Number of subject with Duodenal AE summarized by CTCAE grade and timing |
| Incidence of Resection Following the Completion of Radiation Therapy (RT) | 2-6 weeks post procedure | Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection). |
| Progression Free and Overall Survival | 18 months post procedure | Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month. |
| Radio-Therapy Benefits of TraceIT | 2-6 week assessment | Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution. |
| Feasibility of TraceIT | 2-6 week assessment post-procedure | Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP). |
| TraceIT Persistence (at 6-months Post-treatment) | 2-6 weeks and 6 month post procedure | Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up. |
| Theoretical Dose Escalation From Post-TraceIT Treatment Plan | 2-6 week assessment Post-procedure | Maximum dose to the GTV while maintaining duodenal dose constraints |
Other
| Measure | Time frame | Description |
|---|---|---|
| TraceIT Stability and Space Measurements | Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy | The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP. |
| Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26 | The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning. |
| Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | 2-5 weeks assessment post procedure | Scores for the visualization of the fiducial marker and TraceIT hydrogel. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TraceIT Tissue Spacer TraceIT Tissue Spacer implantation: The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | TraceIT Tissue Spacer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 6 / 6 |
Outcome results
Primary
Safety Endpoint
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
Time frame: 2-6 week assessment post-procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All TIPS Participant | Safety Endpoint | Yes | 0 Participants |
| All TIPS Participant | Safety Endpoint | No | 6 Participants |
Secondary
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Nausea and Vomiting | 13.3 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Fatigue | 11.1 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Cognitive Functioning | 0 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Social Functioning | 20 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Physical functioning | 1.3 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Constipation | 13.3 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Financial Difficulties | 6.7 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Diarrhea | 6.7 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Appetite loss | 6.7 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Change of Global health status | -6.7 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Insomnia | -6.7 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Dyspnea | -13.3 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Emotional Functioning | -5 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Role Functioning | -13.3 Scores on a scale |
| All TIPS Participant | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Pain | 3.3 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Cognitive Functioning | -16.7 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Diarrhea | 0 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Change of Global health status | -11.1 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Emotional Functioning | 5.6 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Social Functioning | -5.6 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Fatigue | 37 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Nausea and Vomiting | 5.6 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Pain | 0 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Dyspnea | -11.1 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Insomnia | 11.1 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Appetite loss | 33.3 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Constipation | -22.2 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Physical functioning | -17.8 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Role Functioning | -50.0 Scores on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Financial Difficulties | -11.1 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Nausea and Vomiting | -6.7 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Appetite loss | 6.7 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Fatigue | 11.1 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Financial Difficulties | 0 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Insomnia | 0 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Emotional Functioning | 6.7 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Role Functioning | 0 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Change of Global health status | 3.3 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Social Functioning | 16.7 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Pain | -10 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Physical functioning | 1.3 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Cognitive Functioning | 3.3 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Constipation | -13.3 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Diarrhea | -6.7 Scores on a scale |
| One or More Late (>3 Months) | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Dyspnea | -20 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Role Functioning | -8.3 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Emotional Functioning | -20.8 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Nausea and Vomiting | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Pain | -8.3 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Dyspnea | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Fatigue | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Financial Difficulties | 16.7 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Insomnia | 16.7 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Appetite loss | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Constipation | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Physical functioning | -10.0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Change of Global health status | -29.2 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Cognitive Functioning | -8.3 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Diarrhea | 0 Scores on a scale |
| 12 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Social Functioning | -16.7 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Physical functioning | -13.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Fatigue | 33.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Social Functioning | -66.7 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Change of Global health status | 0 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Pain | 50 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Emotional Functioning | -33.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Cognitive Functioning | -33.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Constipation | 33.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Insomnia | 33.3 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Dyspnea | 0 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Nausea and Vomiting | 16.7 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Appetite loss | 66.7 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Diarrhea | 0 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Financial Difficulties | 0 Scores on a scale |
| 18 Month | Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) | Role Functioning | -66.7 Scores on a scale |
Secondary
Feasibility of TraceIT
Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).
Time frame: 2-6 week assessment post-procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All TIPS Participant | Feasibility of TraceIT | Yes | 6 Participants |
| All TIPS Participant | Feasibility of TraceIT | No | 0 Participants |
Secondary
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
Number of subject with Duodenal AE summarized by CTCAE grade and timing
Time frame: 18 months post procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 3 duodenal AEs | 2 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who only have grade N/A duodenal AEs | 0 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 5 duodenal AEs | 0 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 2 duodenal AEs | 4 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 1 duodenal AEs | 6 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more duodenal AEs | 6 participants |
| All TIPS Participant | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 4 duodenal AEs | 0 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 5 duodenal AEs | 0 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 2 duodenal AEs | 3 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 3 duodenal AEs | 0 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 4 duodenal AEs | 0 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who only have grade N/A duodenal AEs | 0 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more duodenal AEs | 6 participants |
| 6 Month Follow-up Post Radiation Therapy | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 1 duodenal AEs | 6 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who only have grade N/A duodenal AEs | 0 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 3 duodenal AEs | 2 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 1 duodenal AEs | 4 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more duodenal AEs | 4 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 5 duodenal AEs | 0 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 4 duodenal AEs | 0 participants |
| One or More Late (>3 Months) | Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing | Subjects who have one or more grade 2 duodenal AEs | 3 participants |
Secondary
Incidence of Resection Following the Completion of Radiation Therapy (RT)
Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).
Time frame: 2-6 weeks post procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All TIPS Participant | Incidence of Resection Following the Completion of Radiation Therapy (RT) | Yes | 3 Participants |
| All TIPS Participant | Incidence of Resection Following the Completion of Radiation Therapy (RT) | No | 3 Participants |
Secondary
Progression Free and Overall Survival
Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.
Time frame: 18 months post procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All TIPS Participant | Progression Free and Overall Survival | Progression free survival (subjects with tumor progression event) | 17.6 months | Standard Deviation 4.7 |
| All TIPS Participant | Progression Free and Overall Survival | Overall survival in subjects who died | 20.0 months | Standard Deviation 10.1 |
Secondary
Radio-Therapy Benefits of TraceIT
Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.
Time frame: 2-6 week assessment
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All TIPS Participant | Radio-Therapy Benefits of TraceIT | Yes | 6 Participants |
| All TIPS Participant | Radio-Therapy Benefits of TraceIT | No | 0 Participants |
Secondary
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Maximum dose to the GTV while maintaining duodenal dose constraints
Time frame: 2-6 week assessment Post-procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All TIPS Participant | Theoretical Dose Escalation From Post-TraceIT Treatment Plan | 12.7 Gy | Standard Deviation 19.7 |
Secondary
TraceIT Persistence (at 6-months Post-treatment)
Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.
Time frame: 2-6 weeks and 6 month post procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All TIPS Participant | TraceIT Persistence (at 6-months Post-treatment) | Migration | Yes | 2 Participants |
| All TIPS Participant | TraceIT Persistence (at 6-months Post-treatment) | Persistence | No | 0 Participants |
| All TIPS Participant | TraceIT Persistence (at 6-months Post-treatment) | Persistence | Yes | 3 Participants |
| All TIPS Participant | TraceIT Persistence (at 6-months Post-treatment) | Migration | No | 3 Participants |
| 6 Month Follow-up Post Radiation Therapy | TraceIT Persistence (at 6-months Post-treatment) | Persistence | No | 2 Participants |
| 6 Month Follow-up Post Radiation Therapy | TraceIT Persistence (at 6-months Post-treatment) | Persistence | Yes | 0 Participants |
Other Pre-specified
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26
The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.
Time frame: Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26
Population: Modified Intent to Treat
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Pancreatic Pain | 1.7 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weakness arms and legs | 0 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Altered Bowel Habit | -3.3 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Dry Mouth | -6.7 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Satisfaction with health care | 6.7 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Hepatic Symptoms | -10 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Digestive Symptoms | 30 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Planning of activities | -13.3 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Taste | 6.7 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Sexuality | 0 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Future Worries | 20 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Indigestion | 0 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Bloating | 0 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Trouble with side-effects | -20 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Flatulence | 33.3 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Body Image | 0 score on a scale |
| All TIPS Participant | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weight Loss | 0 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Flatulence | 0 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Future Worries | -11.1 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weakness arms and legs | 22.2 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Satisfaction with health care | -5.6 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Bloating | 11.1 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Hepatic Symptoms | -5.6 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Body Image | -11.1 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Dry Mouth | 22.2 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Indigestion | 0 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Pancreatic Pain | 2.8 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Trouble with side-effects | 22.2 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Digestive Symptoms | 44.4 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Sexuality | 0 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Planning of activities | 44.4 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Altered Bowel Habit | 22.2 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weight Loss | 11.1 score on a scale |
| 6 Month Follow-up Post Radiation Therapy | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Taste | 66.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Altered Bowel Habit | -3.3 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Pancreatic Pain | -10 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Bloating | -6.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Digestive Symptoms | 26.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Taste | -6.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Indigestion | -26.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Flatulence | 13.3 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weight Loss | 0 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weakness arms and legs | 13.3 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Dry Mouth | -13.3 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Hepatic Symptoms | -3.3 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Body Image | 6.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Trouble with side-effects | -6.7 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Future Worries | 0 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Planning of activities | 20 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Satisfaction with health care | 10 score on a scale |
| One or More Late (>3 Months) | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Sexuality | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weakness arms and legs | 33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weight Loss | 33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Altered Bowel Habit | 33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Flatulence | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Body Image | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Indigestion | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Trouble with side-effects | 66.7 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Taste | -33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Pancreatic Pain | 8.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Future Worries | 66.7 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Digestive Symptoms | -16.7 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Planning of activities | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Bloating | 33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Sexuality | -33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Dry Mouth | 33.3 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Satisfaction with health care | 0 score on a scale |
| 12 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Hepatic Symptoms | 50 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Hepatic Symptoms | -16.7 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Future Worries | 33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Digestive Symptoms | 66.7 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Altered Bowel Habit | 16.7 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Flatulence | 0 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Dry Mouth | -33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Satisfaction with health care | -16.7 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Sexuality | 0 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Body Image | 50 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Indigestion | 0 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weight Loss | 33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Pancreatic Pain | 8.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Planning of activities | 33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Trouble with side-effects | 33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Taste | 33.3 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Bloating | 0 score on a scale |
| 18 Month | Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26 | Weakness arms and legs | 33.3 score on a scale |
Other Pre-specified
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel
Scores for the visualization of the fiducial marker and TraceIT hydrogel.
Time frame: 2-5 weeks assessment post procedure
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Fiducial marker visibility scoring | 1-Not visualized | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Fiducial marker visibility scoring | 2-Faint or trace visibility (shadow or haze) | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Fiducial marker visibility scoring | 3-Visibility but indistinct borders (definable entity) | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Fiducial marker visibility scoring | 4-Partially distinct border, partial haze | 1 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | Fiducial marker visibility scoring | 5- Clearly visualized, unequivocal | 5 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | TraceIT hydrogel visibility scoring | 1-Not visualized | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | TraceIT hydrogel visibility scoring | 2-Faint or trace visibility (shadow or haze) | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | TraceIT hydrogel visibility scoring | 3-Visibility but indistinct borders (definable entity) | 2 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | TraceIT hydrogel visibility scoring | 4-Partially distinct border, partial haze | 0 Participants |
| All TIPS Participant | Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel | TraceIT hydrogel visibility scoring | 5- Clearly visualized, unequivocal | 4 Participants |
Other Pre-specified
TraceIT Stability and Space Measurements
The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.
Time frame: Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All TIPS Participant | TraceIT Stability and Space Measurements | TraceIT Space Measurement (mm) | 1.0 mm | Standard Deviation 0 |
| 6 Month Follow-up Post Radiation Therapy | TraceIT Stability and Space Measurements | Stability - Minimum distance from fiducial to TraceIT gel (mm) | 8.2 mm | Standard Deviation 5.9 |
| 6 Month Follow-up Post Radiation Therapy | TraceIT Stability and Space Measurements | TraceIT Space Measurement (mm) | 7.7 mm | Standard Deviation 2.4 |
| One or More Late (>3 Months) | TraceIT Stability and Space Measurements | Stability - Minimum distance from fiducial to TraceIT gel (mm) | 8.5 mm | Standard Deviation 10.2 |