Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: Hexaminolevulinate HCL
* Device: Near Infrared Fluorescence (NIRF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)<br>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. | Drug: Hexaminolevulinate HCL<br>* 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.<br>Device: Near Infrared Fluorescence (NIRF)<br>* NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Dwell Time | The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT). | Day 1 |