Status:
TERMINATED
18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Metastatic Intracranial Malignant Neoplasm
Recurrent Intracranial Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiati...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in pa...
Eligibility Criteria
Inclusion
- Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion')
Exclusion
- Contraindication to contrast enhanced MRI
- Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm)
- Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging
- Inability or refusal to consent
- Allergy or anaphylaxis to any of the reagents used in this study
- Inability or unwillingness to return for required visits and follow-up exams
Key Trial Info
Start Date :
August 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04462419
Start Date
August 18 2020
End Date
November 13 2024
Last Update
September 10 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980