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NCT05676489
MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
EARLY_PHASE1 trial testing [F-18]MeFAMP PET in Healthy Volunteers in 28 participants. Not yet recruiting.
30 August 2027
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 28 |
| Start date | 1 April 2026 |
| Primary completion | 30 August 2027 |
| Estimated completion | 30 August 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [F-18]MeFAMP PET — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Recurrent Glioma — all drugs for Recurrent Glioma →
- Brain Metastases From Extra-cranial Solid Tumors — all drugs for Brain Metastases From Extra-cranial Solid Tumors →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 18 Months to 89, any sex, with Healthy Volunteers or Recurrent Glioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
PET Imaging of System A Amino Acid Transport Detects Early Response to Immune Checkpoint Inhibitor Therapy in a Syngeneic Mouse Model
Akca U, Zhang Y, Yasui N, Hensley C, et al · · 2025 -
Preclinical Comparison of <sup>18</sup>F-Labeled Amino Acids Targeting Different Transporter Systems for PET Imaging of Triple-Negative Breast Cancer.
Akca U, Song PN, Devalankar D, Yasui N, et al · · 2026 · PMID 41506804 · DOI 10.2967/jnumed.125.270225
Verify or expand the search:
- PubMed search for NCT05676489
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05676489 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 20 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05676489.
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