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

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.

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