MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

NCT ID: NCT05676489

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2027-08-30

Brief Summary

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.

Conditions

Healthy Volunteers; Recurrent Glioma; Brain Metastases From Extra-cranial Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers (cohort 1)

Whole Body Dosimetry for healthy volunteers

Group Type: EXPERIMENTAL

[F-18]MeFAMP PET

Intervention Type: DRUG

Study participants will receive the fluorine-18 labeled 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). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.

High Grade Glioma (cohort 2)

Recurrent high grade glioma after radiation therapy

Group Type: EXPERIMENTAL

[F-18]MeFAMP PET

Intervention Type: DRUG

Study participants will receive the fluorine-18 labeled 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). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.

Brain Metastasis (cohort 3)

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

Group Type: EXPERIMENTAL

[F-18]MeFAMP PET

Intervention Type: DRUG

Study participants will receive the fluorine-18 labeled 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). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.

Interventions

[F-18]MeFAMP PET

Study participants will receive the fluorine-18 labeled 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). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older at the time of enrollment

2. Females with childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test on the day of procedure or a serum hCG test within 48 hours prior to the administration MeFAMP.

3. Must have a life expectancy greater than 12 weeks.

1. Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.

2. Normal ECG at baseline.

1. Grade III or Grade IV glioma previously treated with radiation therapy

2. Standard of care contrast-enhanced MRI showing an enhancing lesion at least 1-cm in maximum dimension that is equivocal or suspicious for recurrent glioma.

3. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better

1. At least one brain metastasis from melanoma, lung cancer (small or non-small cell), or breast cancer measuring at least 1-cm in maximum dimension on contrast-enhanced MRI

2. Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan.

3. ECOG performance score of 2 or better

Inclusion of Women and Minorities

Patients 18 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.

Exclusion Criteria

1. Use of an investigational drug for any indication within 3 months prior to the imaging study.

2. Pregnancy or breast feeding

3. Inability to complete the PET scans.

4. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) < 60 mL/min)

5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team.

1) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jonathan E McConathy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan McConathy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Sebastian Eady, BS

Role: CONTACT

RadiologyCRC@uabmc.edu

205-934-1082

Facility Contacts

Sebastian Eady, BS

Role: primary

radiologyCRC@uabmc.edu

205-996-2636

Other Identifiers

R22-225

Identifier Type: -

Identifier Source: org_study_id