Clinical trial · Interventional
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
NCT03058705CI-TRIAL-00040116completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexaminolevulinate HCL | Drug | — | UNRESOLVED |
| Near Infrared Fluorescence (NIRF) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
- 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.
- interventionNames
- Drug: Hexaminolevulinate HCL
- Device: Near Infrared Fluorescence (NIRF)
Primary outcomes (1)
- measure
- Minimal Dwell Time
- timeFrame
- Day 1
- description
- The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.