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NCT06948552
A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Upper Urinary Tract Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
Phase 2 trial testing 5-Aminolevulinic acid Hydrochloride (Gliolan®) in Upper Tract Urothelial Carcinoma in 10 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 10 |
| Start date | 1 April 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 January 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 5-Aminolevulinic acid Hydrochloride (Gliolan®) — full drug profile →
Conditions studied
- Upper Tract Urothelial Carcinoma — all drugs for Upper Tract Urothelial Carcinoma →
Sponsor
Henry Ford Health System — full company profile →
Who can join
Adults 18 to 75, any sex, with Upper Tract Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Detection of tumor fluorescence using 5-ALA under blue light
Time frame: Day of Surgery
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06948552
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 5-Aminolevulinic acid Hydrochloride (Gliolan®)
Trials testing the same drug.
- NCT06665724 — Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodyna · Phase 1 · completed
Other recruiting trials for Upper Tract Urothelial Carcinoma
Currently open trials in the same condition.
- NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
- NCT07321210 — Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma · NA · recruiting
- NCT07225374 — Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC · Phase 2 · recruiting
- NCT07126119 — Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC · Phase 2 · recruiting
- NCT06848868 — Ambulatory Flexible URS for UTUC Surveillance · Phase 1 · recruiting
Other Henry Ford Health System trials
Trials by the same sponsor.
- NCT07450183 — Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 · Phase 2 · not yet recruiting
- NCT07418853 — Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries · NA · not yet recruiting
- NCT06670287 — The Use of Multiple Sensors to Track Sleep in Nightshift Workers · NA · recruiting
- NCT07363525 — Michigan Initial Experience Using Tigertriever for Thrombectomy · not yet recruiting
- NCT07530172 — Radioembolization Versus External Radiation Therapy · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06948552 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
- Last refreshed: 26 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06948552.