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NCT06948552 · ClinicalTrials.gov registry record · Phase 2
Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA
A Phase 2 study, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT06948552: Recruiting Phase 2 study, sponsored by Henry Ford Health System.
NCT06948552 is a Phase 2 study that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06948552, a Phase 2 study, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.
Primary Outcome
Surgeons will assess whether upper tract urothelial tumors exhibit visible fluorescence under blue light following oral administration of 5-ALA (20 mg/kg). Presence or absence of fluorescence will be recorded for each lesion during ureteroscopic resection.
Interventions
- DRUG 5-Aminolevulinic acid Hydrochloride (Gliolan®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-04 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What NCT06948552 shows while recruiting
NCT06948552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Aminolevulinic acid Hydrochloride (Gliolan®) is the first listed.
NCT06948552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06948552 about?
NCT06948552 is a clinical study titled "Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA". This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, an...
What is the current status of trial NCT06948552?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2026-04. Estimated completion is 2028-01.
What interventions are being tested in trial NCT06948552?
The interventions under investigation include: 5-Aminolevulinic acid Hydrochloride (Gliolan®) (DRUG).
Who is sponsoring clinical trial NCT06948552?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06948552's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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