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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03058705|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Hexaminolevulinate HCL Device: Near Infrared Fluorescence (NIRF)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
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).
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
|Contact: Edward M Messing, MDemail@example.com|
|Contact: Scott Quarrier, MDfirstname.lastname@example.org|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Edward M Messing, MD 585-275-0998 email@example.com|
|Contact: Scott Quarrier, MD firstname.lastname@example.org|
|Principal Investigator:||Edward M Messing, MD||University of Rochester|