Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Edward Messing

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: Near Infrared Fluorescence (NIRF); Drug: Hexaminolevulinate HCL

Study type: Interventional

Funder types: Other

Identifiers

NCT03058705

66682

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)

Experimental group

Description:

During the transurethral resection of the bladder procedure, the bladder will initially be examined in a systematic meridian fashion. Suspicious tumors identified by white light only, NIRF only, and both will be identified. If intense fluorescence is observed in the initial patient(s) at 10 min, dwell duration will be reduced to 5 min for the next patient(s); if abundant fluorescence is detected there as well, dwell duration will be shortened again to 2.5 min. At least three patients will be studied at each duration to document intense fluorescence before proceeding to shorter instillation durations in subsequent patients.

Treatment:

Device: Near Infrared Fluorescence (NIRF)

Drug: Hexaminolevulinate HCL