N/A
Completed N=10
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Source: ClinicalTrials.gov NCT03058705 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: 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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimal Dwell Time |
— | — |
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. Informational only — not medical advice.