Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Drug: Hexaminolevulinate HCL; Device: Near Infrared Fluorescence (NIRF)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Device Feasibility
Official Title:	Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
Actual Study Start Date :	November 28, 2017
Actual Primary Completion Date :	July 25, 2018
Actual Study Completion Date :	July 25, 2018

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Hexaminolevinulate HCL with 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.

Drug: Hexaminolevulinate HCL; 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.; Device: Near Infrared Fluorescence (NIRF); NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.

Outcome Measures

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Primary Outcome Measures :

1. Minimal Dwell Time [ Time Frame: Day 1 ]
   The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642

Sponsors and Collaborators

Edward Messing

Imagin Medical

Investigators

Principal Investigator:	Edward M Messing, MD	University of Rochester

More Information

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Responsible Party:	Edward Messing, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier:	NCT03058705 History of Changes
Other Study ID Numbers:	66682
First Posted:	February 23, 2017
Last Update Posted:	July 27, 2018
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Product Manufactured in and Exported from the U.S.:		Yes

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Urinary Bladder Diseases; Urologic Diseases; Aminolevulinic Acid; Photosensitizing Agents; Dermatologic Agents