Near Infrared Fluorescence Imaging for Bladder Cancer Detection

NCT ID: NCT03058705

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-28
• Study Completion Date: 2018-07-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hexaminolevulinate HCL

Intervention Type: 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.

Near Infrared Fluorescence (NIRF)

Intervention Type: DEVICE

NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imagin Medical

UNKNOWN

Sponsor Role: collaborator

Edward Messing

OTHER

Sponsor Role: lead

Responsible Party

Edward Messing

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edward M Messing, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

66682

Identifier Type: -

Identifier Source: org_study_id