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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: Clinical Trial Early Phase 1 study, sponsored by University of Alabama at Birmingham.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What is known before NCT05676489 opens enrollment
NCT05676489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which [F-18]MeFAMP PET is the first listed.
NCT05676489 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05676489's enrollment target sits among peer trials
28 938th of 2000 higher than 1,038 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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