Near Infrared Fluorescence Imaging for Bladder Cancer Detection

NCT03058705 | Completed Results FDA Device

• 1 other identifier: 66682
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Minimal Dwell Time

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

  Day 1

Study Arms (1)

Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)

EXPERIMENTAL

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; Device: Near Infrared Fluorescence (NIRF)

Interventions

Hexaminolevulinate HCL DRUG

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.

Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)

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.

Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Messing: lead
• Imagin Medical: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Edward Messing, MD
• Organization: University of Rochester

edward_messing@urmc.rochester.edu

585-275-0998

Study Officials

• Edward M Messing, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: November 28, 2017
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-08

Locations

US (1)