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

10 Participants Needed

Trial Summary

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.

Is 5-Aminolevulinic Acid safe for use in humans?

5-Aminolevulinic Acid has been used in treatments for bladder cancer, but it can cause side effects like hypotension (low blood pressure). Some studies report no significant adverse effects, but more detailed safety information is still needed. ^{1 2 3 4 5}

How is the drug 5-Aminolevulinic Acid unique in treating urothelial carcinoma?

5-Aminolevulinic Acid is unique because it is used in photodynamic therapy, where it helps to identify and kill cancer cells by making them glow under a special light and producing toxic substances that destroy the tumor. This approach is different from traditional treatments as it specifically targets cancer cells while sparing healthy ones, and it leverages a common cancer cell property known as the Warburg effect. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Clinical experience with intravesical instillations of 5-aminolevulinic acid (5-ALA) for the photodynamic diagnosis using fluorescence cystoscopy for bladder cancer]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Early clinical experience with 5-aminolevulinic acid for the photodynamic therapy of superficial bladder cancer. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

5-Aminolevulinic acid-induced severe hypotension during transurethral resection of a bladder tumor: a case report. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

An open pharmacokinetic study of hexylaminolevulinate-induced photodiagnosis after intravesical administration. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Whole bladder photodynamic therapy with 5-aminolevulinic acid using a white light source. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Current status of photodynamic technology for urothelial cancer. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro evaluation of cytotoxic properties of 5-Aminolevulinic acid (5-ALA) on bladder cancer cells. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Photodynamic effects of 5-aminolevulinic acid-induced porphyrin on human bladder carcinoma cells in vitro. [2019]