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

Blue Earth Diagnostics

Status and phase: Completed; Phase 3

Conditions: Brain Metastases

Treatments: Drug: 18F fluciclovine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04410133

BED-FLC-312

Details and patient eligibility

About

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

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Patients

Experimental group

Description:

Single intravenous administration of 18F fluciclovine for PET Scan

Treatment:

Drug: 18F fluciclovine