Clinical trial NCT04410367: Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 23
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-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


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

Primary outcomes:
measure: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
timeFrame: 60 days
measure: Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
timeFrame: 60 days
Secondary outcomes:
measure: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake
timeFrame: 60 days
measure: Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.
timeFrame: 60 days
measure: Treatment-emergent Adverse Events
timeFrame: From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.
Other outcomes:
Locations:
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
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
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: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Blue Earth Diagnostics
name: Eugene Teoh, MD
role: STUDY_DIRECTOR
affiliation: Miami Cancer Institute
name: Rupesh Kotecha, MD
role: PRINCIPAL_INVESTIGATOR
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.