Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA

September 15, 2026 updated by: Johar Raza, Henry Ford Health System

A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

5-Aminolevulinic Acid (5-ALA), Gleolan, Kidney Cancer, Renal Cell Carcinoma, Partial Nephrectomy, Photodynamic Diagnosis (PDD), Fluorescence-Guided Surgery, Blue Light Imaging, Tumor Detection, Surgical Margins, Safety Profile, Adverse Events, Clinical Trial, Robotic Surgery, Pathology, Fluorescence Imaging, Renal Tumors, Pilot Study, Diagnostic Accuracy, Phase III Trial

This pilot clinical study aims to evaluate the safety and efficacy of 5-aminolevulinic acid (5-ALA; Gleolan) as a fluorescence-guided imaging agent for patients undergoing partial nephrectomy for suspected kidney cancer. Although 5-ALA is currently FDA-approved for visualization of high-grade gliomas during neurosurgery, emerging evidence suggests that it may also improve the detection of renal tumors through photodynamic diagnosis (PDD). The investigators hypothesize that oral administration of 5-ALA will cause kidney tumors to fluoresce under blue light, allowing surgeons to more easily identify tumors and assess resection margins while maintaining a favorable safety profile with minimal adverse events.

The study plans to enroll 10 adult patients aged 18 to 75 years who have kidney tumors amenable to standard-of-care partial nephrectomy. Eligible participants must have good performance status (ECOG 0-1) and adequate renal, hepatic, and hematologic function. Patients with significant cardiovascular disease, active liver disease, poorly controlled infections, pregnancy, porphyria-related hypersensitivity, or other major comorbidities will be excluded.

After informed consent is obtained, patients will undergo baseline laboratory testing including a comprehensive metabolic panel (CMP), liver function tests, lactate dehydrogenase (LDH), and γ-glutamyl transferase (GGT). On the day of surgery, participants will receive 20 mg/kg of oral 5-ALA dissolved in water approximately 2-4 hours before the procedure. Patients will be monitored preoperatively for known side effects such as nausea, vomiting, hypotension, and photosensitivity.

The surgical procedure will follow standard robotic partial nephrectomy techniques, with the addition of fluorescence imaging. Surgeons will first visualize the exposed tumor under white light and capture images. The operative field will then be examined using a specially modified blue-light imaging system to determine whether the tumor exhibits fluorescence. Following tumor excision under standard white light, the resection bed will again be examined with blue light to identify any residual fluorescent tissue that may indicate remaining tumor. If concerning fluorescence is observed, additional tissue margins may be resected and sent separately for pathological examination.

The primary outcomes include the ability of blue-light fluorescence imaging to detect kidney tumors and assist in evaluating residual disease. Investigators will compare tumor detection under white light versus blue light and calculate sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) using final surgical pathology as the gold standard. Receiver operating characteristic (ROC) curve analysis will be used to compare diagnostic performance between imaging modalities.

This proof-of-concept study seeks to determine whether 5-ALA fluorescence-guided surgery can improve intraoperative visualization of kidney tumors while maintaining an acceptable safety profile. Positive findings could support larger studies and potentially justify advancement to a Phase III clinical trial investigating fluorescence-guided kidney cancer surgery.

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 Contact

  • Name: Peace Deh, MD
  • Phone Number: 313-916-7699
  • Email: pdeh1@hfhs.org

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • 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
  • 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

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.

Other Name:

Other Names:
  • 5-ALA
  • Gleolan

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: Intra-operatively
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.
Intra-operatively

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 after intervention
Incidence and severity (Grade 1-5, CTCAE v5.0) of adverse events related to 5-ALA administration (e.g., hypotension, GI effects, liver enzyme elevation, photosensitivity)
Up to 30 days after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final tumor pathology
Time Frame: Up to 2 weeks post-operatively
Presence or absence of residual tumor after resection
Up to 2 weeks post-operatively

Collaborators and Investigators

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

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Johar Raza, MD, Henry Ford Health

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)

September 15, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFH-IRB18380
  • IRB18380 (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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