N/A
N=10
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03058705 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Minimal Dwell Time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hexaminolevulinate HCL (Drug); Near Infrared Fluorescence (NIRF) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edward Messing
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimal Dwell Time |
— | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03058705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.