Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Edward Messing10 enrolled

Overview

The primary outcome of this study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

Hexaminolevulinate HCLDRUG

Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose.

Near Infrared Fluorescence (NIRF)DEVICE

NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor. * Planned transurethral resection of bladder tumor in the operating room. * Ability to give informed consent. * Willing to spend time for the study * Men or women (age 18 or older) * Any racial or ethnic origin Exclusion Criteria: * Pregnancy * Nursing mother * Diagnosis of porphyria * Gross hematuria * BCG immunotherapy or intravesical chemotherapy within the past 90 days * Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Minimal Dwell Time

The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).

Time frame: Day 1

Data from ClinicalTrials.gov

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