NCT04114370 (FACBC) is a EARLY_PHASE1 clinical trial of 18F-fluciclovine in Glioma, sponsored by James Mountz.

Who is sponsoring NCT04114370?

NCT04114370 is sponsored by James Mountz.

What drugs are being tested in NCT04114370?

Interventions in NCT04114370: 18F-fluciclovine.

Is NCT04114370 still recruiting?

NCT04114370 is currently completed. Last updated 6 December 2022.

Last reviewed 2022-12-06 · How we verify

NCT04114370: FACBC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

Completed EARLY_PHASE1 Last updated 6 December 2022

What this trial tests

EARLY_PHASE1 trial testing 18F-fluciclovine in Glioma in 9 participants. Completed in 30 September 2021.

Timeline

22 October 2019

Primary endpoint
18 May 2021

30 September 2021

Quick facts

Lead sponsor	James Mountz
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	9
Start date	22 October 2019
Primary completion	18 May 2021
Estimated completion	30 September 2021
Sites	1 location across United States

Drugs / interventions tested

18F-fluciclovine

Conditions studied

Glioma — all drugs for Glioma →

Sponsor

James Mountz

Who can join

18 and older, any sex, with Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot study to assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. \[F-18\]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after \[F-18\]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation.
Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, et al · · 2021 · cited 1× · PMID 34081125 · DOI 10.1093/neuonc/noab097

Verify or expand the search:

Other trials of 18F-fluciclovine

Trials testing the same drug.

NCT06062745 — Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT · Phase 1 · recruiting
NCT04852523 — 18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants · EARLY_PHASE1 · completed
NCT05035732 — A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/M · NA · withdrawn
NCT04018053 — 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy · EARLY_PHASE1 · active not recruiting
NCT03930173 — 18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis · EARLY_PHASE1 · completed

Other recruiting trials for Glioma

Currently open trials in the same condition.

NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
NCT07236840 — Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors · recruiting
NCT07450872 — Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors · recruiting
NCT07405372 — Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas · recruiting
NCT07338539 — BIO-SHORT: Biologically Guided Short-Course Hypofractionated RT for Poor-Prognosis GBM · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04114370 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 James Mountz
Last refreshed: 6 December 2022

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/NCT04114370.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing