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

March 26, 2026 updated by: Johar Raza, Henry Ford Health System

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-ALA Fluorescence Imaging
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®)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of tumor fluorescence using 5-ALA under blue light
Time Frame: Day of Surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events following 5-ALA administration
Time Frame: Up to 30 days post-procedure
Participants will be monitored for any adverse events following oral 5-ALA administration. Events will be assessed using CTCAE v5.0 criteria, with specific focus on known side effects such as nausea, vomiting, hypotension, and photosensitivity reactions. Lab abnormalities and any serious adverse events will also be documented.
Up to 30 days post-procedure
Presence of residual tumor at follow-up ureteroscopy
Time Frame: Up to 3 months post-procedure
For patients who undergo a second-look ureteroscopy within 3 months of initial resection, surgeons will assess for visible tumor at the prior resection sites. Findings will be used to evaluate the completeness of initial resection and the potential benefit of 5-ALA fluorescence guidance.
Up to 3 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFH-IRB17325
  • IRB17325 (Other Identifier: Henry Ford Health IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single-site, investigator-initiated feasibility study funded through an internal philanthropic research grant. Individual participant data will not be shared, as there is no formal data-sharing infrastructure in place and the study is not intended to support regulatory submissions or external data analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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