TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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TraceIT TM Hydrogel Tissue Marker for Patients Receiving Definitive Chemoradiation for Bladder Cancer

Conditions
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Bladder Carcinoma

Intervention / Treatment
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* Device: Polyethylene Glycol Hydrogel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (TracelT hydrogel)<br>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. | Device: Polyethylene Glycol Hydrogel<br>* Given TracelT hydrogel via injection<br>* Other names: PEG Hydrogel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Up to 1 year | 
| 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. | Up to 8 weeks |