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

NCT07828704 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: HFH-IRB18380IRB18380
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancers

Keywords

5-Aminolevulinic Acid (5-ALA); Gleolan; Kidney Cancer; Partial Nephrectomy; Photodynamic Diagnosis; Fluorescence-Guided Surgery; Renal Cell Carcinoma; Minimally Invasive Surgery; Urologic Oncology; Blue Light

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  Up to 30 days after intervention

Other Outcomes (1)

• Final tumor pathology

  Up to 2 weeks post-operatively

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. Other Name:

Also known as: Gleolan, 5-ALA

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
• Has indications for standard-of-care partial nephrectomy
• 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 Health

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (6)

• Yamamoto S, Fukuhara H, Karashima T, Inoue K. Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety. Photodiagnosis Photodyn Ther. 2020 Dec;32:101999. doi: 10.1016/j.pdpdt.2020.101999. Epub 2020 Sep 10.

  PMID: 32920180 BACKGROUND

• Hoda MR, Popken G. Surgical outcomes of fluorescence-guided laparoscopic partial nephrectomy using 5-aminolevulinic acid-induced protoporphyrin IX. J Surg Res. 2009 Jun 15;154(2):220-5. doi: 10.1016/j.jss.2008.12.027. Epub 2009 Jan 14.

  PMID: 19375717 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

• 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

• 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

• 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

Related Links

• Primary FDA Approval Citation

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

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; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

• Johar Raza, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peace Deh, MD

CONTACT

313-916-7699; pdeh1@hfhs.org

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: July 29, 2026
• First Posted: September 18, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)