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BRIEF TITLE: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer

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


  • Org Study ID: 66682
  • Secondary ID:
  • NCT ID: NCT03058705
  • NCT Alias:
  • Sponsor: Edward Messing - Other
  • Source: University of Rochester

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).

Overal Status Start Date Phase Study Type
Recruiting November 28, 2017 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Minimal Dwell Time

Primary Outcome 1 - Time Frame: Day 1

Condition:

  • Bladder Cancer

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Edward M Messing, MD

Role: Principal Investigator

Affiliation: University of Rochester

Overall Contact

Name: Edward M Messing, MD

Phone: 585-275-0998

Email: edward_messing@urmc.rochester.edu

Location

Facility Status Contact
University of Rochester Medical Center
Rochester, New York 14642
United States
Recruiting Edward M Messing, MD
585-275-0998
edward_messing@urmc.rochester.edu