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

Primary Purpose

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

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
[F-18]MeFAMP PET
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy Volunteers

Eligibility Criteria

18 Months - 89 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for all cohorts: 18 years of age or older at the time of enrollment 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. Must have a life expectancy greater than 12 weeks. Exclusion Criteria for all cohorts: Use of an investigational drug for any indication within 3 months prior to the imaging study. Pregnancy or breast feeding Inability to complete the PET scans. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) < 60 mL/min) Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team. 6.4.9.3. Inclusion criteria specific to Dosimetry Cohort Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline. Normal ECG at baseline. Exclusion criteria specific to Dosimetry Cohort 1) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team. Inclusion Criteria specific to HGG Cohort Grade III or Grade IV glioma previously treated with radiation therapy 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. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better Inclusion Criteria specific to Metastasis Cohort 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 Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Healthy Volunteers (cohort 1)

    High Grade Glioma (cohort 2)

    Brain Metastasis (cohort 3)

    Arm Description

    Whole Body Dosimetry for healthy volunteers

    Recurrent high grade glioma after radiation therapy

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

    Outcomes

    Primary Outcome Measures

    Human dosimetry for [F-18]MeFAMP.
    The changing concentrations of radioactivity in normal organs and tissues will be measured in each participant at 3 time points after [F-18]MeFAMP injection in Cohort 1. These data will be used to estimate human dosimetry as effective dose in milliSieverts.
    Safety of [F-18]MeFAMP
    Laboratory values including complete metabolic panel (CMP) and complete blood count with differential (CBC with diff) and adverse events will be assessed before and after [F-18]MeFAMP administration in cohort 1. Electrocardiograms (ECG) will also be performed before and after study drug administration in cohort 1 to assess for QT prolongation and changes in heart rate, rhythm, and ECG waveforms that could represent a safety signal due to the study drug.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2022
    Last Updated
    August 29, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05676489
    Brief Title
    MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
    Official Title
    MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2024 (Anticipated)
    Primary Completion Date
    August 30, 2026 (Anticipated)
    Study Completion Date
    August 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy Volunteers, Recurrent Glioma, Brain Metastases From Extra-cranial Solid Tumors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Volunteers (cohort 1)
    Arm Type
    Experimental
    Arm Description
    Whole Body Dosimetry for healthy volunteers
    Arm Title
    High Grade Glioma (cohort 2)
    Arm Type
    Experimental
    Arm Description
    Recurrent high grade glioma after radiation therapy
    Arm Title
    Brain Metastasis (cohort 3)
    Arm Type
    Experimental
    Arm Description
    Brain metastases from extra-cranial solid tumors before and after radiation therapy
    Intervention Type
    Drug
    Intervention Name(s)
    [F-18]MeFAMP PET
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Human dosimetry for [F-18]MeFAMP.
    Description
    The changing concentrations of radioactivity in normal organs and tissues will be measured in each participant at 3 time points after [F-18]MeFAMP injection in Cohort 1. These data will be used to estimate human dosimetry as effective dose in milliSieverts.
    Time Frame
    From injection to 45 minutes, 2 hours, and 4 hours after PET agent administration.
    Title
    Safety of [F-18]MeFAMP
    Description
    Laboratory values including complete metabolic panel (CMP) and complete blood count with differential (CBC with diff) and adverse events will be assessed before and after [F-18]MeFAMP administration in cohort 1. Electrocardiograms (ECG) will also be performed before and after study drug administration in cohort 1 to assess for QT prolongation and changes in heart rate, rhythm, and ECG waveforms that could represent a safety signal due to the study drug.
    Time Frame
    Lab values, ECG and adverse events will be assessed on the day of the study before and after administration of [F-18]MeFAMP for cohort 1.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for all cohorts: 18 years of age or older at the time of enrollment 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. Must have a life expectancy greater than 12 weeks. Exclusion Criteria for all cohorts: Use of an investigational drug for any indication within 3 months prior to the imaging study. Pregnancy or breast feeding Inability to complete the PET scans. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) < 60 mL/min) Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team. 6.4.9.3. Inclusion criteria specific to Dosimetry Cohort Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline. Normal ECG at baseline. Exclusion criteria specific to Dosimetry Cohort 1) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team. Inclusion Criteria specific to HGG Cohort Grade III or Grade IV glioma previously treated with radiation therapy 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. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better Inclusion Criteria specific to Metastasis Cohort 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 Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sebastian Eady, BS
    Phone
    205-934-1082
    Email
    RadiologyCRC@uabmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan McConathy, MD, PhD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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