Clinical Trial · NCT04410133

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

Overview

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy

Sponsor

Blue Earth Diagnostics, LTD

Phase

Phase 3

ClinicalTrials.gov

NCT04410133

Drug / Compound

fluciclovine

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
Previous history of solid tumor brain metastasis of any origin
Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC
Previous radiation therapy of brain metastatic lesion(s)
Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years

Exclusion

1\. Patients with a history of active hematological malignancy

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

Loading…