Bladder Carcinoma
Conditions
Brief summary
This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.
Detailed description
PRIMARY OBJECTIVES: I. To utilize the TraceIT hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (TURBT). II. To improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers. SECONDARY OBJECTIVES: I. To report adverse events surrounding the placement of the TraceIT tissue marker. II. To calculate the actual dose received by the bladder tumor bed, as delineated by the hydrogel. III. To compare the dosimetric impact to the tumor bed of daily patient alignment to the pelvic bones, versus alignment to the whole bladder, versus alignment to the hydrogel markers. IV. To calculate the amount of normal tissue radiation dose decrease achievable without losing tumor coverage, with better tumor targeting with hydrogel placement. OUTLINE: Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.
Interventions
Given TracelT hydrogel via injection
Sponsors
National Cancer Institute (NCI)
University of Washington
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
* Histologically confirmed malignancy of the bladder * No prior cystectomy * Treatment plan for bladder must include at least 4 weeks of daily radiation treatment (most patients will receive chemotherapy concurrent with radiation, but this is not required for trial enrollment) * Patient must undergo TraceIT hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer * Participants must have a complete history and physical examination within 60 days of study entry * Participants must be able to provide informed consent for treatment and trial participation * No restrictions on prior treatment to be eligible
Exclusion criteria
* Prior cystectomy * Unable to have TraceIT hydrogel placement \< 8 weeks prior to beginning radiation treatment * Treatment for metastatic bladder cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates | Baseline up to 8 weeks | Daily changes will be compared across the patient group as well as within each subjects' treatment course. |
| Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates | Baseline up to 8 weeks | Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym | Up to 8 weeks | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on alignment to the hydrogel location, versus alignment to whole bladder location, versus alignment to bony anatomy. |
| Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location | Up to 8 weeks | Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on hydrogel location. Total radiation dose to the PTV can then be calculated as the sum of the daily dose. |
| Number of Participants With Adverse Events Caused by Hydrogel | Up to 1 year | Graded by the Common Terminology Criteria in Adverse Events version 4.0 |
| Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) | Up to 8 weeks | Daily pre-radiation imaging will be used to identify the smallest setup margin required for consistent coverage of the GTV, which is likely smaller than the current standard of care setup margin of at least 2 cm around the GTV. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care (TracelT Hydrogel) Patients undergo transurethral resection of bladder tumors and receive TracelT hydrogel via injection. Patients undergo standard of care radiation therapy within 8 weeks of TracelT hydrogel placement.
Polyethylene Glycol Hydrogel: Given TracelT hydrogel via injection | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Supportive Care (TracelT Hydrogel) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 10 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Age, Continuous | 73 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 Participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates
Daily changes will be compared across the patient group as well as within each subjects' treatment course.
Time frame: Baseline up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (TracelT Hydrogel) | Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates | 0.62 cm | Standard Error 0.54 |
Comparison: Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.
Primary
Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates
Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient.
Time frame: Baseline up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (TracelT Hydrogel) | Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates | 0.21 cm | Standard Error 0.48 |
Secondary
Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym
Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on alignment to the hydrogel location, versus alignment to whole bladder location, versus alignment to bony anatomy.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (TracelT Hydrogel) | Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym | 95 percentage of total dose | Standard Error 2 |
Secondary
Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location
Daily pre-radiation imaging will be used to run the radiation treatment plan, to calculate the daily dose to the PTV based on hydrogel location. Total radiation dose to the PTV can then be calculated as the sum of the daily dose.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (TracelT Hydrogel) | Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location | 99 percentage of total dose | Standard Error 2 |
Secondary
Number of Participants With Adverse Events Caused by Hydrogel
Graded by the Common Terminology Criteria in Adverse Events version 4.0
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (TracelT Hydrogel) | Number of Participants With Adverse Events Caused by Hydrogel | 0 Participants |
Secondary
Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)
Daily pre-radiation imaging will be used to identify the smallest setup margin required for consistent coverage of the GTV, which is likely smaller than the current standard of care setup margin of at least 2 cm around the GTV.
Time frame: Up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (TracelT Hydrogel) | Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) | 10 mm | Standard Deviation 3 |