Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Drug: Hexaminolevulinate HCL; Device: Near Infrared Fluorescence (NIRF)

• Registration Number: NCT03058705
• Lead Sponsor: Edward Messing

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Study Start: 2017-11-28
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-25
• Results First Submitted: 2019-07-01
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-15
• Last Update Submitted: 2019-08-15
• Results First Posted: 2019-08-19
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)	Hexaminolevulinate HCL	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.
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)	Near Infrared Fluorescence (NIRF)	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.

Primary Outcome Measures

Name	Time	Method
Minimal Dwell Time	Day 1	The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States