Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration 2. Previous history of solid tumor brain metastasis of any origin 3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years 4. Previous radiation therapy of brain metastatic lesion(s) 5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis 6. 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

Exclusion Criteria

  1. Patients with a history of active hematological malignancy

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Positron Emission Tomography (PET) Imaging study
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients
Single intravenous administration of 18F fluciclovine for PET Scan
  • Drug: 18F fluciclovine
    18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
    Other names:
    • Axumin

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Jonathan McConathy
jmcconathy@uabmc.edu

More Details

Status
Recruiting
Sponsor
Blue Earth Diagnostics

Study Contact

Dawn Serkin
+1 215-272-1833
Dawn.Serkin@precisionformedicine.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.