Clinical trial · Interventional
Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA
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
NCT06948552CI-TRIAL-00119836recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma | Renal Pelvis and Ureter Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic acid Hydrochloride (Gliolan®) | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-ALA Fluorescence Imaging
- description
- Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.
- interventionNames
- Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)
Primary outcomes (1)
- measure
- Detection of tumor fluorescence using 5-ALA under blue light
- timeFrame
- Day of Surgery
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 or older undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor * Able to provide informed consent * Able to comply with study requirements Exclusion Criteria: * Known porphyria or hypersensitivity to porphyrins * Pregnant or breastfeeding women * AST or ALT \> 2x upper limit of normal within 30 days prior to surgery * Participation in another investigational study within 30 days * Known allergy or contraindication to 5-ALA or its components
References
Publications (5)
- BACKGROUNDTaoka R, Matsuoka Y, Yamasaki M, Kani N, Honda T, Harada S, Tohi Y, Kato T, Okazoe H, Tsunemori H, Ueda N, Sugimoto M. Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer. Photodiagnosis Photodyn Ther. 2022 Jun;38:102838. doi: 10.1016/j.pdpdt.2022.102838. Epub 2022 Apr 4. PMID 35381368
- BACKGROUNDWatanabe K, Tamura K, Matsushita Y, Watanabe H, Motoyama D, Ito T, Sugiyama T, Otsuka A, Miyake H. Significance of 5-Aminolevulinic Acid-mediated Photodynamic Diagnosis Following Standard Transurethral Resection in Non-muscle Invasive Bladder Cancer. Cancer Diagn Progn. 2021 Jul 3;1(3):201-205. doi: 10.21873/cdp.10027. eCollection 2021 Jul-Aug. PMID 35399308
- BACKGROUNDNakai Y, Inoue K, Tsuzuki T, Shimamoto T, Shuin T, Nagao K, Matsuyama H, Oyama M, Furuse H, Ozono S, Miyake M, Fujimoto K. Oral 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A multicenter phase III study. Int J Urol. 2018 Aug;25(8):723-729. doi: 10.1111/iju.13718. Epub 2018 Jul 12. PMID 29999205
- BACKGROUNDYoshida T, Setsuda S, Ishizuka M, Inoue T, Kinoshita H, Matsuda T. Photodynamic Diagnosis with Oral 5-Aminolevulinic Acid for Upper Urinary Tract Carcinoma: A Prospective Clinical Trial. J Endourol. 2020 Apr;34(4):509-515. doi: 10.1089/end.2019.0725. Epub 2020 Mar 31. PMID 31964177
- BACKGROUNDFukuhara H, Kurabayashi A, Furihata M, Setuda S, Takahashi K, Murakami K, Tanaka T, Inoue K. 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence ureterorenoscopy for urinary upper tract urothelial carcinoma approximately Preliminary prospective single centre trial approximately . Photodiagnosis Photodyn Ther. 2020 Mar;29:101617. doi: 10.1016/j.pdpdt.2019.101617. Epub 2019 Dec 16. PMID 31857216