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

NCT03125226 | Completed Results DMC FDA Device

• 4 other identifiers: 9798NCI-2017-00525P30CA015704RG3117001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  Up to 8 weeks

• Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location

  Up to 8 weeks

• Number of Participants With Adverse Events Caused by Hydrogel

  Up to 1 year

• Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)

  Up to 8 weeks

Study Arms (1)

Supportive care (TracelT hydrogel)

EXPERIMENTAL

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

Interventions

Polyethylene Glycol Hydrogel DEVICE

Given TracelT hydrogel via injection

Also known as: PEG Hydrogel

Supportive care (TracelT hydrogel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior cystectomy
• Unable to have TraceIT hydrogel placement \< 8 weeks prior to beginning radiation treatment
• Treatment for metastatic bladder cancer

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Jing Zeng
• Organization: University of Washington School of Medicine

jzeng13@uw.edu

2065985998

Study Officials

• Jing Zeng

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: October 5, 2017
• Primary Completion: January 1, 2020
• Study Completion: May 18, 2020
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Locations

US (1)