Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA

NCT06948552 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: HFH-IRB17325IRB17325
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Tract Urothelial Carcinoma

Keywords

Photodynamic Diagnosis; 5-ALA; Gleolan; Ureteroscopy; Fluorescence Endoscopy; Urothelial Cancer; Blue Light; Kidney Cancer; Urologic Oncology; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Detection of tumor fluorescence using 5-ALA under blue light

  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.

  Day of Surgery

Secondary Outcomes (2)

• Incidence and severity of adverse events following 5-ALA administration

  Up to 30 days post-procedure

• Presence of residual tumor at follow-up ureteroscopy

  Up to 3 months post-procedure

Study Arms (1)

5-ALA Fluorescence Imaging

EXPERIMENTAL

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.

Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)

Interventions

5-Aminolevulinic acid Hydrochloride (Gliolan®) DRUG

Participants will receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to surgery. The goal is to evaluate the feasibility of using fluorescence cystoscopy with blue light to improve tumor detection and visualization during ureteroscopic resection of upper tract urothelial carcinoma.

5-ALA Fluorescence Imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (5)

• Taoka 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 BACKGROUND

• Watanabe 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 BACKGROUND

• Nakai 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 BACKGROUND

• Yoshida 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 BACKGROUND

• Fukuhara 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 BACKGROUND

Related Links

• Primary FDA Approval Citation

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Oncologist, Henry Ford Health

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)