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NCT05676489 · ClinicalTrials.gov registry record · Early Phase 1
MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
A Early Phase 1 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT05676489 is a Early Phase 1 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 28 participants.
The verdict
NCT05676489, a Early Phase 1 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG [F-18]MeFAMP PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2027-04-01 |
| Est. Completion | 2029-08-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05676489
The ClinicalTrials.gov registry entry for NCT05676489 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [F-18]MeFAMP PET is the first listed.
NCT05676489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05676489 about?
NCT05676489 is a clinical study titled "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 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 ...
What is the current status of trial NCT05676489?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2027-04-01. Estimated completion is 2029-08-30.
What interventions are being tested in trial NCT05676489?
The interventions under investigation include: [F-18]MeFAMP PET (DRUG).
Who is sponsoring clinical trial NCT05676489?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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