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

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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

INTRODUCTION

  • Org Study ID: HFH-IRB17325
  • Secondary ID: N/A
  • NCT ID: NCT06948552
  • Sponsor: Henry Ford Health System

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.

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    April, 2026
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Detection of tumor fluorescence using 5-ALA under blue light

Primary Outcome 1 - Timeframe: Day of Surgery

CONDITION

  • Upper Tract Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States 		Status: Recruiting Contact: Contact
Johar Raza, MD
313-585-0578
[email protected]

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