5-Aminolevulinic Acid for Urothelial Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether 5-aminolevulinic acid (5-ALA), already used in brain surgery, can help doctors better see and remove tumors in the urinary tract. Patients will take 5-ALA before surgery, and surgeons will use a special blue light to spot tumors that regular lighting might miss. The aim is to improve tumor detection and removal during surgery. This trial may suit individuals scheduled for urinary tract tumor surgery who can meet the study's requirements. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this technique is safe for improving tumor visibility?
Research has shown that 5-aminolevulinic acid (5-ALA) is generally safe in medical treatments. In previous studies, patients tolerated it well even after several hours of exposure. The FDA has approved 5-ALA for use in brain surgery, indicating its safety. Although specific side effects are not detailed in the sources, the existing approval and past research suggest that most people do not experience major problems with 5-ALA.12345
Why do researchers think this study treatment might be promising for urothelial carcinoma?
Unlike standard treatments for urothelial carcinoma, which typically involve surgical resection or chemotherapy, 5-aminolevulinic acid (5-ALA) offers a unique approach by enhancing tumor visibility during surgery. This treatment uses a special technique called fluorescence imaging, where 5-ALA is taken orally before surgery. It causes cancerous tissues to glow under a blue light, helping surgeons to see and remove tumors more effectively. Researchers are excited about this because it could lead to more precise surgeries and potentially better outcomes for patients.
What evidence suggests that this technique is effective for improving tumor visibility in urothelial carcinoma?
Research has shown that 5-aminolevulinic acid (5-ALA), which participants in this trial will receive, helps doctors see tumors better by making them glow under a special blue light. Studies have found that 5-ALA makes cancerous tissues easier to spot, leading to more accurate tumor detection. In one study, using 5-ALA helped find and remove more bladder tumors. Another study demonstrated that this method could lower the chances of tumors returning. These findings suggest that 5-ALA might effectively enhance tumor visibility during surgery, potentially leading to better outcomes.12367
Are You a Good Fit for This Trial?
This trial is for individuals with upper tract urothelial carcinoma, a type of cancer that affects the urinary system. Participants should be scheduled for ureteroscopic tumor resection surgery. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 5-ALA 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy is used intraoperatively to assess tumor fluorescence and aid in visualization and resection.
Follow-up
Participants are monitored for adverse events following 5-ALA administration and for residual tumor presence at follow-up ureteroscopy.
What Are the Treatments Tested in This Trial?
Interventions
- 5-Aminolevulinic acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor