Near Infrared Fluorescence Imaging for Bladder Cancer Detection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03058705 |
Recruitment Status :
Completed
First Posted : February 23, 2017
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer | Drug: Hexaminolevulinate HCL Device: Near Infrared Fluorescence (NIRF) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058705
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Edward M Messing, MD | University of Rochester |
Documents provided by Edward Messing, University of Rochester:
Responsible Party: | Edward Messing, Principal Investigator, University of Rochester |
ClinicalTrials.gov Identifier: | NCT03058705 |
Other Study ID Numbers: |
66682 |
First Posted: | February 23, 2017 Key Record Dates |
Results First Posted: | August 19, 2019 |
Last Update Posted: | August 19, 2019 |
Last Verified: | August 2019 |
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 |
Product Manufactured in and Exported from the U.S.: | Yes |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |