Gastrointestinal Bleeding, Hemoptysis, Malignancy, Mediastinal Disease, Metastasis, Pelvic Bleeding, Superior Vena Cava Syndrome
Conditions
Brief summary
This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.
Interventions
DEVICEVolumetric MR imaging
This will most frequently be supine with arms positioned so not in the way of treatment beams.
RADIATIONRadiation therapy
-Standard of care
Sponsors
Washington University School of Medicine
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
* Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT) * Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease. * At least 18 years of age. * Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion criteria
* Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry. * Medical contraindication to undergoing MR imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. | Completion of enrollment (approximately 29 months) |
Countries
United States
Participant flow
Pre-assignment details
Patients would be considered evaluable for the study if they were able to be scheduled for radiation treatment per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Volumetric MR Imaging Planning * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.
* Patients will receive standard of care palliative radiation therapy | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Previously unidentified metal artifact | 1 |
| Overall Study | Unable to tolerate lying flat on MR table | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Volumetric MR Imaging Planning |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 2 / 16 |
Outcome results
Primary
Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.
Time frame: Completion of enrollment (approximately 29 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Volumetric MR Imaging Planning | Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. | 16 Participants |