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

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Carcinoma
• Intervention / Treatment: Device: Polyethylene Glycol Hydrogel

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: PEG Hydrogel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 18, 2020

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 9798 (Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2017-00525 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG3117001 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes