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

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


  • Org Study ID: 9798
  • Secondary ID: NCI-2017-00525,9798,P30CA015704
  • NCT ID: NCT03125226
  • NCT Alias:
  • Sponsor: University of Washington - Other
  • Source: University of Washington

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.

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.

Overal Status Start Date Phase Study Type
Recruiting October 5, 2017 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Changes in interfraction motion of the marker measured by cone beam computed tomography (CT) and x/y/z coordinates

Primary Outcome 1 - Time Frame: Baseline up to 8 weeks

Primary Outcome 2 - Measure: Changes in tumor bed size and shape as delineated by the hydrogel and measured by cone beam CT and x/y/z coordinates

Primary Outcome 2 - Time Frame: Baseline up to 8 weeks

Condition:

  • Bladder Carcinoma

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jing Zeng

Role: Principal Investigator

Affiliation: Fred Hutch/University of Washington Cancer Consortium

Location

Facility Status Contact
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States
Recruiting Jing Zeng
206-598-4100
jzeng13@uw.edu