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

Blue Earth Diagnostics151 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

151

Conditions

Brain Metastases

Interventions

18F fluciclovineDRUG

18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level

Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Secondary Outcomes

Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)

Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

To assess lesion-level PPA \& NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)

To assess lesion-level PPV \& NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type

Data from ClinicalTrials.gov

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St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

John Wayne Cancer Institute at Providence St. John's Health Center

Santa Monica, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Medical College of Georgia, Augusta University

Augusta, Georgia, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

...and 9 more locations

Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to primary tumor type.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type

Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to primary tumor type.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy

Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.

Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

Clinical Usefulness

Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.

Time frame: Follow up through 6 months after PET scan.

Clinical Usefulness

Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI

Time frame: Follow up through 6 months after PET scan.

Clinical Usefulness

Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.

Time frame: Follow up through 6 months after PET scan.

Inter-reader Reproducibility

Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \[1st reader\] / Positive \[2nd reader\], Negative/Negative) is presented.

Time frame: PET Scan Day 1

Intra-reader Reproducibility

Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive \[initial read\] / Positive \[re-read\], Negative/Negative) is presented.

Time frame: PET Scan Day 1

Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure

Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate

Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate

Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature

Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.