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

Bladder Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125226
• Other study ID #: 9798
• Secondary ID: NCI-2017-0052597
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: May 18, 2020

Study information

• Verified date: February 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 18, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Device:
• Polyethylene Glycol Hydrogel
Given TracelT hydrogel via injection

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline up to 8 weeks
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.	Baseline up to 8 weeks
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.	Up to 8 weeks
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.	Up to 8 weeks
Secondary	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
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.	Up to 8 weeks