[F-18]MeFAMP PET for Brain Tumors

Overseen By Sebastian Eady, BS

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Investigational drugs

Disqualifiers: Pregnancy, Breastfeeding, Renal dysfunction, others

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

Compensation: Varies

Number of Visits: 2

28 Participants Needed

Trial Summary

What is the purpose of this trial?

This first-in-human study will establish the human safety and radiation dosimetry of the system A amino acid transport substrate, (R)-3-\[F-18\]fluoro-2-methyl-2-(methylamino)propanoic acid (\[F-18\]MeFAMP), for positron emission tomography (PET) imaging of primary and metastatic brain tumors. This study will include 3 cohorts: healthy volunteers for whole body dosimetry estimates (n=6-8, Dosimetry Cohort), patients undergoing evaluation for recurrent high grade glioma after radiation therapy (n=10, high grade glioma (HGG) Cohort), and patients with brain metastases from extra-cranial solid tumors before and after radiation therapy (n=10, Metastasis Cohort). Exploratory assessment of the diagnostic accuracy of MeFAMP for distinguishing recurrent/progressive brain tumors from radiation-related treatment effects will also be performed for subsequent trial design. The study will complete accrual and safety assessment in the Dosimetry Cohort before recruiting for the HGG and Metastasis Cohorts.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you have used an investigational drug within 3 months prior to the study.

What data supports the effectiveness of the treatment [F-18]MeFAMP PET for brain tumors?

The effectiveness of similar PET imaging treatments, like [18F]FDOPA and [18F]FET, has been shown in brain tumor diagnostics, helping to differentiate between tumor recurrence and treatment-related changes, and improving treatment planning and monitoring. These treatments provide important diagnostic information that could potentially be applicable to [F-18]MeFAMP PET. ^{1 2 3 4 5}

How is [F-18]MeFAMP PET different from other brain tumor treatments?

[F-18]MeFAMP PET is unique because it uses a special imaging technique called positron emission tomography (PET) to help doctors see brain tumors more clearly. This method can provide better contrast between tumor tissue and healthy brain tissue, which helps in planning treatment and monitoring progress, unlike standard MRI scans. ^{1 2 3 6 7}

Research Team

Jonathan McConathy, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with a life expectancy of more than 12 weeks. It includes healthy volunteers, those with high-grade glioma after radiation, and patients with brain metastases from other tumors. Women able to have children must test negative for pregnancy.

Inclusion Criteria

You are expected to live for more than 12 weeks.

Women who could become pregnant must have a negative pregnancy test before the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry Assessment

Whole body dosimetry estimates for healthy volunteers to establish human safety and radiation dosimetry of [F-18]MeFAMP

1 day

1 visit (in-person)

Safety Assessment

Safety assessment including laboratory values, ECG, and adverse events before and after [F-18]MeFAMP administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• [F-18]MeFAMP PET

Trial Overview [F-18]MeFAMP PET imaging is being tested to see if it's safe and how well it can show primary and metastatic brain tumors. The study has three parts: one for healthy people, one for glioma patients, and another for those with brain metastases.

Participant Groups

Group I: High Grade Glioma (cohort 2) Experimental Treatment 1 Intervention

Recurrent high grade glioma after radiation therapy

Group II: Healthy Volunteers (cohort 1) Experimental Treatment 1 Intervention

Whole Body Dosimetry for healthy volunteers

Group III: Brain Metastasis (cohort 3) Experimental Treatment 1 Intervention

Brain metastases from extra-cranial solid tumors before and after radiation therapy

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

PET imaging with the amino acid analogue [18F]FET has proven effective in brain tumor diagnostics, providing critical information for tumor delineation, therapy planning, and monitoring treatment responses.

[18F]FET shows low accumulation in benign lesions and healthy brain tissue, allowing for clear differentiation between tumor and non-tumor areas, which has led to its preference over shorter-lived tracers like [11C]MET in many Western European medical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in the use of O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) in neurooncology. Stegmayr, C., Stoffels, G., Filß, C., et al.[2021]

Amino-acid PET imaging, particularly using 18F-DOPA, is increasingly recommended alongside MRI for evaluating and managing brain tumors, as it provides valuable insights at various stages of treatment.

There is strong evidence supporting the use of 18F-DOPA in adults for brain tumor evaluations, and emerging data suggests its effectiveness in pediatric cases as well, highlighting its potential for broader clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amino Acid PET Imaging with 18F-DOPA in the evaluation of Pediatric Brain Tumors. Djekidel, M., Alsadi, R., Bouhali, O., et al.[2022]

[18F]FDG remains the most widely used radiotracer for PET studies in brain tumors, providing significant prognostic value and aiding in treatment decisions despite its lower sensitivity for low-grade lesions.

The combination of PET with CT is expected to enhance the sensitivity and specificity of [18F]FDG, particularly in differentiating between tumor relapse and necrosis, although further research is needed to fully understand its advantages over other imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG-PET/CT. Chierichetti, F., Pizzolato, G.[2016]

In a study involving 13 rats with implanted glioblastoma cells, [18F]fluciclovine PET showed similar sensitivity for detecting tumor burden compared to conventional MRI, with median sensitivities of 0.67 for PET and 0.61 for MRI.

Combining [18F]fluciclovine PET with MRI significantly improved detection sensitivity to 0.86, which was 41% higher than MRI alone, indicating that using both imaging techniques together may enhance the assessment of brain tumor burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. Chen, P., Scarpelli, ML., Healey, DR., et al.[2023]

References

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

Current trends in the use of O-(2-[18F]fluoroethyl)-L-tyrosine ([18F]FET) in neurooncology. [2021]

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

Amino Acid PET Imaging with 18F-DOPA in the evaluation of Pediatric Brain Tumors. [2022]

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

Factors affecting ¹⁸F FDOPA standardized uptake value in patients with primary brain tumors after treatment. [2015]

4. England pubmed.ncbi.nlm.nih.gov

¹⁸F-fluorodopa positron-emission tomography: an emerging imaging modality for patients with brain metastases. [2016]

5. Italy pubmed.ncbi.nlm.nih.gov

18F-FDG-PET/CT. [2016]

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

Brain tumor imaging with synthesized 18F-fluorophenylalanine and positron emission tomography. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. [2023]