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

• ClinicalTrials.gov Identifier: NCT03125226
• Recruitment Status: Completed
• First Posted: April 24, 2017
• Results First Posted: February 25, 2021
• Last Update Posted: February 25, 2021
• Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jing Zeng, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bladder Carcinoma	Device: Polyethylene Glycol Hydrogel	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TraceIT TM Hydrogel Tissue Marker for Patients Receiving Definitive Chemoradiation for Bladder Cancer
• Actual Study Start Date: October 5, 2017
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: May 18, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: Polyethylene Glycol Hydrogel; Given TracelT hydrogel via injection; Other Name: PEG Hydrogel

Outcome Measures

Primary Outcome Measures :

1. Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates [ Time Frame: Baseline up to 8 weeks ]
   Daily changes will be compared across the patient group as well as within each subjects' treatment course.
2. Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates [ Time Frame: 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 Outcome Measures :

1. 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 [ Time Frame: 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.
2. Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location [ Time Frame: 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.
3. Number of Participants With Adverse Events Caused by Hydrogel [ Time Frame: Up to 1 year ]
   Graded by the Common Terminology Criteria in Adverse Events version 4.0
4. Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jing Zeng; Fred Hutch/University of Washington Cancer Consortium

  Study Documents (Full-Text)

Documents provided by Jing Zeng, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] February 19, 2020

More Information

• Responsible Party: Jing Zeng, Associate Professor, Department of Radiation Oncology, University of Washington
• ClinicalTrials.gov Identifier: NCT03125226
• Other Study ID Numbers: 9798; NCI-2017-00525 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 9798 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); P30CA015704 ( U.S. NIH Grant/Contract ); RG3117001 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
• First Posted: April 24, 2017
• Results First Posted: February 25, 2021
• Last Update Posted: February 25, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases