Active, not recruiting • Phase O • Stage IV • Post-Menopausal • Brain Metastases present • Interventional
The following is imported from ClinicalTrials.gov:
18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases
This early phase I trial tests the use of a radioactive tracer (a drug that is visible during an imaging test) known as 18F-FMAU, for imaging with positron emission tomography/computed tomography (PET/CT) in patients with brain cancer or cancer that has spread to the brain (brain metastases). A PET/CT scan is an imaging test that uses a small amount of radioactive tracer (given through the vein) to take detailed pictures of areas inside the body where the tracer is taken up. 18F-FMAU may also help find the cancer and how far the disease has spread. Magnetic resonance imaging (MRI) is a type of imaging test used to diagnose brain tumors. 18F-FMAU PET/CT in addition to MRI may make the finding and diagnosing of brain tumor easier.
PRIMARY OBJECTIVES:
I. Assess the correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic 2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (FMAU) PET kinetic analysis parameters.
II. Explore the different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters between patients with presence or absence of recurrent tumor.
OUTLINE:
Patients receive 18F-FMAU intravenously (IV) and undergo a PET/CT scan over 60 minutes. Patients then undergo standard of care mpMRI over approximately 45 minutes.
After completion of study intervention, patients are followed up at 24-96 hours after their 18F-FMAU PET/CT scan.
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
10 participant
Actual study start date:
February 15, 2021
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
both
Arms and Intervention
Computed Tomography
18F-FMAU
Multiparametric Magnetic Resonance Imaging
Positron Emission Tomography
Inclusion criteria
age > 18 years, both men and women
documented history of either primary brain tumor (e.g. glioma) or metastatic brain tumor from another primary cancer (e.g. lung, breast, colon, melanoma, kidney)
documented radiation therapy regardless of treatments prior to radiation therapy
Exclusion criteria
unable to give consent
inability to remain motionless during imaging studies
intractable seizures
claustrophobia
implantable devices incompatible with magnetic resonance (mr) environment