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

University of Washington

Status: Completed

Conditions: Bladder Carcinoma

Treatments: Device: Polyethylene Glycol Hydrogel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03125226

9798 (Other Identifier)

RG3117001 (Other Identifier)

NCI-2017-00525 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Supportive care (TracelT hydrogel)

Experimental group

Description:

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.

Treatment:

Device: Polyethylene Glycol Hydrogel