Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Daniel M. Trifiletti, M.D.|
|Principal Investigator Affiliation||Mayo Clinic|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Metastatic Intracranial Malignant Neoplasm, Recurrent Intracranial Neoplasm|
|Study Website:||View Trial Website|
- I. To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (MRI) findings suggesting recurrent disease, using histopathology as proof of disease.
- I. To determine static fluciclovine PET standardized uptake value (SUV)peak, SUVmean values and metabolic tumor volumes (MTV) which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using serial MRI as a surrogate marker of disease.
- II. To determine early dynamic fluciclovine PET time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using histopathology or serial MRI as a marker of disease.
- III. To correlate the determined static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival.
- IV. In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology.
: Diagnostic (18F-fluciclovine, PET/MRI imaging)
Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.
Radiation: - Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography
Undergo PET-MRI imaging
Other: - Fluciclovine F18
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.