[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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new PET imaging method, called [F-18]MeFAMP PET, to evaluate its safety and effectiveness in detecting brain tumors. It targets specific groups: healthy volunteers, individuals with high-grade glioma after radiation, and those with brain metastases (tumors spread to the brain from other cancers) both before and after treatment. The goal is to determine if the imaging can distinguish between tumor growth and changes from previous treatments. Individuals with brain metastases from melanoma, lung cancer, or breast cancer who plan to undergo radiation treatment soon might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the imaging method works in people, offering participants the chance to be among the first to benefit from this innovative approach.

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 prior data suggests that [F-18]MeFAMP PET is safe for human use?

Research shows that [F-18]MeFAMP PET is under study to determine its safety and effectiveness for imaging brain tumors. This method is being tested in people for the first time. As an early study, limited information exists on how well participants tolerate [F-18]MeFAMP.

The study aims to assess safety by measuring radiation exposure and monitoring for side effects. In this early phase trial, ensuring the method does not cause harm is crucial before progressing to larger studies. If [F-18]MeFAMP proves safe at this stage, it could become a valuable tool for improved brain tumor imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the [F-18]MeFAMP PET technique because it offers a new way to visualize and measure brain tumors. Unlike traditional imaging methods like MRI or CT scans, which provide structural information, [F-18]MeFAMP PET uses a radiotracer to highlight metabolic activity in brain tumors, potentially offering more precise insights into tumor behavior. This could help in tailoring treatments more effectively and monitoring how well a tumor responds to therapy. By focusing on metabolic changes, this method might reveal tumor responses earlier than current imaging options, which could be crucial for adjusting treatment plans promptly.

What evidence suggests that [F-18]MeFAMP PET is effective for imaging brain tumors?

Research shows that a new imaging method called [F-18]MeFAMP PET holds promise for diagnosing brain tumors. This trial will evaluate [F-18]MeFAMP PET in various cohorts, including healthy volunteers, patients with high-grade glioma, and those with brain metastasis. Studies have found that similar substances, like [F-18]FET, effectively detect tumors and assist doctors in selecting treatments. Early research indicates that [F-18]MeFAMP can quickly provide clear images of tumors, crucial for accurate diagnosis. Tests on animals demonstrated that this imaging method works well for different tumor types, suggesting it could aid in cases of brain cancer that has spread. The evidence suggests that [F-18]MeFAMP could be a valuable tool for better understanding and managing brain tumors. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan McConathy, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/61/supplement_1/519

18 F]MeFAMP, a system A amino acid transport imaging agent (R)-[18F]MeFAMP has shown promising results for imaging brain tumors and other malignancies in preclinical models.1-4. Methods: An efficient ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4268243/

System A Amino Acid Transport-Targeted Brain and ... These preclinical studies demonstrate good imaging properties in a wide range of tumors for all four amino acids evaluated with (R)-[18F]2 having the highest ...

3. withpower.com withpower.com/trial/early-phase-1-brain-neoplasms-7-2023-a2e17

[F-18]MeFAMP PET for Brain Tumors · Info for Participants PET imaging with the amino acid analogue [18F]FET has proven effective in brain tumor diagnostics, providing critical information for tumor delineation, therapy ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3644424/

Radiosynthesis and Biological Evaluation of alpha-[F-18] ... MicroPET imaging demonstrated good tumor visualization within 10 min of injection, rapid uptake of radioactivity, and tumor to brain ratios of ...

5. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/cgi/viewcontent.cgi?article=1583&context=etd-collection

Comparison of [18F]FDG with 18F-Labeled Amino Acids for ... Hypothesis: Radiolabeled amino acid tracers will provide higher tumor to muscle and tumor to the brain than [18F]FDG. Aim 2. Quantify amino acid transporters in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05676489

MeFAMP for Imaging System a Amino Acid Transport in ... 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 ...

7. trials.braintumor.org trials.braintumor.org/?page=227

Filters - Clinical Trial Finder - National Brain Tumor Society MeFAMP for Imaging System a Amino Acid Transport in Primary and Metastatic Brain Tumors. This first-in-human study will establish the human safety and radiation ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36502457/

18F-FET-PET imaging in high-grade gliomas and brain ... 18 F-FET shows promise as a complementary modality to standard-of-care MRI for the management of primary and metastatic brain malignancies.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-10994

MeFAMP for Imaging of High Grade Glioma, or Melanoma ... This early phase I trial tests the safety and dosing of [18F]MeFAMP for patients with high grade glioma (HGG) or melanoma, lung or breast cancer that has ...