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

Henry Ford Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Upper Tract Urothelial Carcinoma

Treatments: Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06948552

HFH-IRB17325

IRB17325 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients undergoing ureteroscopic resection for suspected upper tract urothelial carcinoma (UTUC). 5-ALA is an FDA-approved oral agent used in glioma surgery to promote fluorescence of malignant tissue under blue light. This study will evaluate whether similar visualization can be achieved in the upper urinary tract to aid in the identification and resection of UTUC. Up to 10 participants will be enrolled. Safety, technical feasibility, and tumor detection outcomes will be measured.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

5-ALA Fluorescence Imaging

Experimental group

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.

Treatment:

Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)