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.
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
Single group
5-Aminolevulinic acid Hydrochloride (Gliolan®)
DrugParticipants 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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
