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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
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.
Henry Ford Hospital
Detroit, Michigan, United States
Detection of tumor fluorescence using 5-ALA under blue light
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.
Time frame: Day of Surgery
Incidence and severity of adverse events following 5-ALA administration
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.
Time frame: Up to 30 days post-procedure
Presence of residual tumor at follow-up ureteroscopy
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.
Time frame: Up to 3 months post-procedure
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