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Clinical trial

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

ID
Name
BED-FLC-219
Description
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Trial arms
Trial start
2020-08-31
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Completed
Phase
Early phase I
Treatment
18F fluciclovine
18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus
Arms:
Patients
Other names:
Axumin
Size
23
Primary endpoint
Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
60 days
Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
60 days
Eligibility criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 2. Previous history of solid tumor brain metastasis of any origin 3. Histopathological confirmation of the primary solid tumor or a metastatic site 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 craniotomy Exclusion Criteria: 1. Patients with a history of active hematological malignancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Positron Emission Tomography (PET) Imaging study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

1 product

1 abstract

1 indication

Product
18F Fluciclovine
Indication
Brain Metastases
Organization
Blue Earth Diagnostics
Abstract
Evaluating the diagnostic performance of 18F-fluciclovine for detection of recurrent brain metastases after radiation therapy: Results from a prospective phase 2 trial.
Org: Department of Neurosurgery, Prince of Wales Hospital, Department of Radiation Oncology, Baptist Health South Florida, Perelman School of Medicine, Department of Radiology,