Clinical trial NCT04410133: Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Official title: An Open-label, Single-arm, Single-dose, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Metastases
Keywords: Recurrent Brain Metastases
Diagnostic
Positron Emission Tomography (PET) Scan
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Precision For Medicine
First posted: 2020-06-01
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Positron Emission Tomography (PET) Imaging study
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
timeFrame: 6 months
measure: Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
timeFrame: 6 months
Secondary outcomes:
measure: Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
timeFrame: 6 months
measure: Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
timeFrame: 6 months
measure: Treatment-emergent adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence St. John's Health Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia, Augusta University
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Center for Clinical Imaging Research
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Cleveland
country: United States
facility: University Hospital Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
state: Utah
city: Morgantown
country: United States
facility: West Virgina University Cancer Institute
state: West Virginia
Study officials:
References:
citation: Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. 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. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.