This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Near Infrared Fluorescence Imaging for Bladder Cancer Detection

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified July 2017 by Edward Messing, University of Rochester
Imagin Medical
Information provided by (Responsible Party):
Edward Messing, University of Rochester Identifier:
First received: February 16, 2017
Last updated: July 18, 2017
Last verified: July 2017
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 Intervention
Bladder Cancer Drug: Hexaminolevulinate HCL Device: Near Infrared Fluorescence (NIRF)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Edward Messing, University of Rochester:

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

Estimated Enrollment: 10
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT03058705

Contact: Edward M Messing, MD 585-275-0998
Contact: Scott Quarrier, MD

Sponsors and Collaborators
Edward Messing
Imagin Medical
Principal Investigator: Edward M Messing, MD University of Rochester
  More Information

Responsible Party: Edward Messing, Principal Investigator, University of Rochester Identifier: NCT03058705     History of Changes
Other Study ID Numbers: 66682
Study First Received: February 16, 2017
Last Updated: July 18, 2017
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: 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
Urinary Bladder Diseases
Urologic Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents processed this record on September 21, 2017