Clinical trial · Interventional
Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
- 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)
The goal of this prospective, single-arm feasibility study is to evaluate the safety and feasibility of using Gleolan® (5-aminolevulinic acid), an FDA-approved drug currently used during brain tumor surgery, in adults with suspected kidney cancer undergoing partial nephrectomy. Gleolan has shown promise in improving the visualization of cancerous tissue, and this study aims to assess its potential use in urologic oncology. The main questions it aims to answer are: * Is Gleolan safe and well tolerated in patients with suspected kidney cancer undergoing partial nephrectomy? * Is the use of Gleolan feasible for fluorescence-guided identification of kidney cancer lesions during surgery? Participants will: * Receive Gleolan before surgery according to the study protocol. * Undergo partial nephrectomy, during which fluorescence imaging will be used to evaluate the visualization of kidney tumor tissue. * Be monitored for safety outcomes and any adverse events before, during, and after surgery.
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 |
|---|---|---|---|
| Kidney Cancers | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
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
- Intra-operatively
- description
- Surgeons will assess whether renal tumors exhibit visible fluorescence under blue light following oral administration of 5-ALA (20 mg/kg). The presence or absence of fluorescence will be recorded for each lesion during partial nephrectomy.
Secondary outcomes (1)
- 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 * Has indications for standard-of-care partial nephrectomy * 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 (6)
- BACKGROUNDYamamoto S, Fukuhara H, Karashima T, Inoue K. Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety. Photodiagnosis Photodyn Ther. 2020 Dec;32:101999. doi: 10.1016/j.pdpdt.2020.101999. Epub 2020 Sep 10. PMID 32920180
- BACKGROUNDHoda MR, Popken G. Surgical outcomes of fluorescence-guided laparoscopic partial nephrectomy using 5-aminolevulinic acid-induced protoporphyrin IX. J Surg Res. 2009 Jun 15;154(2):220-5. doi: 10.1016/j.jss.2008.12.027. Epub 2009 Jan 14. PMID 19375717
- 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
- 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
- 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
- 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.