Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA
- Conditions
- Upper Tract Urothelial Carcinoma
- Interventions
- Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)
- Registration Number
- NCT06948552
- Lead 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5-ALA Fluorescence Imaging 5-Aminolevulinic acid Hydrochloride (Gliolan®) 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.
- Primary Outcome Measures
Name Time Method Detection of tumor fluorescence using 5-ALA under blue light 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.
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events following 5-ALA administration 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.
Presence of residual tumor at follow-up ureteroscopy 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.
Trial Locations
- Locations (1)
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States