5-Aminolevulinic Acid for Urothelial Carcinoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry Ford Health System

Disqualifiers: Porphyria, Pregnancy, Liver issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Day of Surgery

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

Able to provide informed consent

Able to comply with study requirements

I am 18 or older and need a procedure for a possible upper urinary tract cancer.

Exclusion Criteria

Pregnant or breastfeeding women

Participation in another investigational study within 30 days

Known porphyria or hypersensitivity to porphyrins

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Day of Surgery

Follow-up

Participants are monitored for adverse events following 5-ALA administration and for residual tumor presence at follow-up ureteroscopy.

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• 5-Aminolevulinic acid

Trial Overview

The trial tests if taking 5-aminolevulinic acid (5-ALA) before surgery can make cancer in the urinary tract more visible when using blue light during surgery. This could potentially improve the detection and removal of tumors compared to standard white light.

How Is the Trial Designed?

Group I: 5-ALA Fluorescence Imaging Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

5-Aminolevulinic acid is a highly specific photosensitizer that has been effectively used in diagnosing and treating urological cancers, particularly bladder cancer, through techniques like photodynamic diagnosis and therapy.

This compound works by exploiting the Warburg effect, a common characteristic of cancer cells, suggesting its potential application in treating a wide range of cancer types beyond urological cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of photodynamic technology for urothelial cancer. Inoue, K., Fukuhara, H., Yamamoto, S., et al.[2022]

A 68-year-old man experienced severe hypotension (blood pressure dropping to 47/32 mmHg) after receiving 5-aminolevulinic acid (5-ALA) for bladder tumor surgery, highlighting a significant adverse effect associated with this drug.

Standard treatments for hypotension, such as phenylephrine and ephedrine, were ineffective, necessitating the use of adrenaline to stabilize blood pressure, suggesting that anesthesiologists should be cautious and consider 5-ALA as a potential cause of hypotension during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-Aminolevulinic acid-induced severe hypotension during transurethral resection of a bladder tumor: a case report. Yatabe, T., Marie, SL., Fukuhara, H., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8272758/

5-ALA-Induced Fluorescent Cytology in the Diagnosis of ...

Our study shows that 5-ALA-induced fluorescent cytology is highly sensitive test to diagnose bladder cancer and shows a significant difference especially in low ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1572100020303537

Real-world experience with 5-aminolevulinic acid for the ...

ALA-PDD showed sufficient diagnostic accuracy even after more than 4 h of ALA exposure prior to surgery, as well as acceptable safety profiles.

3.

urotoday.com

urotoday.com/conference-highlights/eau-2025/eau-2025-bladder-cancer/159176-eau-2025-diagnostic-accuracy-and-efficacy-of-photodynamic-diagnosis-4-8-hours-after-5-aminolevulinic-acid-hydrochloride-administration-for-non-muscle-invasive-bladder-cancer-an-exploratory-analysis-of-the-phase-iii-spp2c102-trial.html

An Exploratory Analysis of the Phase III SPP2C102 Trial

The objective of this study was to determine the diagnostic accuracy of PDD with 5-ALA for specific anatomical sites and tumor types and the potential patient ...

4.

auajournals.org

auajournals.org/doi/10.1097/01.ju.0000181814.73466.14

LONG-TERM BENEFIT OF 5-AMINOLEVULINIC ACID ...

As shown in various studies 5-aminolevulinic acid (ALA) induces fluorescence of malignant and dysplastic bladder tissue and increases tumor detection rates by ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17445650/

8-year Results of Prospective Randomized Study

The results have suggested a reduced rate of recurrent tumors with the use of 5-ALA fluorescence before bladder tumor resection. We performed a prospective, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06948552

Study Details | NCT06948552 | Photodynamic Diagnosis of ...

This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.6_suppl.489

Reduction of residual tumors by photodynamic diagnosis ...

Photodynamic diagnosis-assisted TURBT (PDD-TURBT) using 5-aminolevulinic acid (5-ALA) has been reported to reduce residual tumors and intravesical recurrence.