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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Given TracelT hydrogel via injection
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
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
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
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
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
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
Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)
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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