Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058705
• Other study ID #: 66682
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: August 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Edward Messing	Imagin Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Dwell Time	The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).	Day 1