18F-fluciclovine PET Discrimination of Radiation Injury to the Brain
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 19-004459
NCT ID: NCT04462419
Sponsor Protocol Number: MC1975
About this study
The goal of this study is to further evaluate the ability of fluciclovine PET to discriminate between radiation necrosis and tumor progression in patients with previously irradiated intracranial metastatic disease.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Registration – Inclusion Criteria
- Age ≥ 18 years old.
- 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’).
Registration - Exclusion Criteria:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Daniel Trifiletti, M.D.
Contact us for the latest status
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available