Back to resultsNear Infrared Fluorescence Imaging for Bladder Cancer Detection
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hexaminolevulinate HCL
Near Infrared Fluorescence (NIRF)
Sponsored by
About this trial
This is an interventional device feasibility trial for 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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
Arm Description
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.
Outcomes
Primary Outcome Measures
Minimal Dwell Time
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Secondary Outcome Measures
Full Information
NCT ID
NCT03058705
First Posted
February 16, 2017
Last Updated
August 15, 2019
Sponsor
Edward Messing
Collaborators
Imagin Medical
1. Study Identification
Unique Protocol Identification Number
NCT03058705
Brief Title
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Official Title
Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Messing
Collaborators
Imagin Medical
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hexaminolevulinate HCL
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Near Infrared Fluorescence (NIRF)
Intervention Description
NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.
Primary Outcome Measure Information:
Title
Minimal Dwell Time
Description
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward M Messing, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
We'll reach out to this number within 24 hrs