ALA-induced PpIX Fluorescence for Brain Tumor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: David W. Roberts

Disqualifiers: Pregnancy, Photosensitivity, Liver disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

540 Participants Needed

Trial Summary

What is the purpose of this trial?

Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

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 trial coordinators or your doctor.

What data supports the effectiveness of the drug 5-aminolevulinic acid for brain tumor treatment?

Research shows that using 5-aminolevulinic acid (5-ALA) during brain tumor surgery helps doctors see and remove more of the tumor, especially in high-grade gliomas like glioblastoma. This approach has been shown to double the extent of tumor removal and improve the time patients remain free from tumor progression for six months. ^{1 2 3 4 5}

Is 5-aminolevulinic acid (ALA) safe for use in humans?

5-aminolevulinic acid (ALA) has been used safely in brain tumor surgeries to help doctors see and remove tumors more completely. It is generally well-tolerated when used in the recommended doses for these procedures. ^{1 3 5 6 7}

How does the drug 5-aminolevulinic acid (5-ALA) differ from other treatments for brain tumors?

5-aminolevulinic acid (5-ALA) is unique because it causes tumor cells to produce a fluorescent compound called protoporphyrin IX (PpIX), which helps surgeons see and remove brain tumors more accurately during surgery. This fluorescence-guided approach is particularly useful for distinguishing between tumor tissue and normal brain tissue, which is a challenge with other treatments. ^{4 8 9 10 11}

Research Team

David W. Roberts, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 21 with a brain tumor diagnosis suitable for surgery, without serious psychiatric illnesses. It's not for pregnant or breastfeeding women, those with photosensitivity issues, recent liver disease, dermatitis, or high creatinine levels.

Inclusion Criteria

My tumor can be surgically removed through an open skull surgery.

Patient or LAR able to provide written informed consent

No serious associated psychiatric illnesses

Exclusion Criteria

Pregnant women or women who are breast feeding

Inability to comply with the photosensitivity precautions associated with the study

My kidney function test showed creatinine over 180umol/L recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5-aminolevulinic acid (20mg/kg) 3 hours prior to surgery for brain tumor resection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to five years

Treatment Details

Interventions

• 5-aminolevulinic acid

Trial Overview The study tests the use of a substance called 5-aminolevulinic acid (ALA) to make tumor cells glow during surgery. This could help surgeons see and remove the entire tumor more effectively.

Participant Groups

Group I: Experimental: 5-aminolevulinic acid Experimental Treatment 1 Intervention

20mg/kg 3 hours prior to surgery

Who Is Running the Clinical Trial?

David W. Roberts

Lead Sponsor

Trials

3

Recruited

680+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

References

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

Characterizing the heterogeneity in 5-aminolevulinic acid-induced fluorescence in glioblastoma. [2021]

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

5-aminolevulinic acid induced protoporphyrin IX (ALA-PpIX) fluorescence guidance in meningioma surgery. [2020]

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

Fluorescence-guided resection of brain tumor: review of the significance of intraoperative quantification of protoporphyrin IX fluorescence. [2020]

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

Quantitative fluorescence in intracranial tumor: implications for ALA-induced PpIX as an intraoperative biomarker. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Low dose 5-aminolevulinic acid: Implications in spectroscopic measurements during brain tumor surgery. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Quantitative Modulation of PpIX Fluorescence and Improved Glioma Visualization. [2020]

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

Noninvasive measurement of aminolevulinic acid-induced protoporphyrin IX fluorescence allowing detection of murine glioma in vivo. [2021]

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

Two-peaked 5-ALA-induced PpIX fluorescence emission spectrum distinguishes glioblastomas from low grade gliomas and infiltrative component of glioblastomas. [2021]

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

Characterization of autofluorescence and quantitative protoporphyrin IX biomarkers for optical spectroscopy-guided glioma surgery. [2022]

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

Spectral complexity of 5-ALA induced PpIX fluorescence in guided surgery: a clinical study towards the discrimination of healthy tissue and margin boundaries in high and low grade gliomas. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

Fluorescence-guided resection of metastatic brain tumors using a 5-aminolevulinic acid-induced protoporphyrin IX: pathological study. [2016]