Bladder Cancer Clinical Trial
Official title:
Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
NCT number | NCT03058705 |
Other study ID # | 66682 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 28, 2017 |
Est. completion date | July 25, 2018 |
Verified date | August 2019 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 10 |
Est. completion date | July 25, 2018 |
Est. primary completion date | July 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Edward Messing | Imagin Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimal Dwell Time | The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT). | Day 1 |
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