NCT04752267

18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases

Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Glioma
• Malignant Brain Neoplasm
• Metastatic Breast Carcinoma
• Metastatic Colon Carcinoma
• Metastatic Kidney Carcinoma
• Metastatic Lung Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Melanoma
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Stage IV Colon Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IVA Colon Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Colon Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8
• Stage IVC Colon Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	18F-FMAU	Given IV
PROCEDURE	Multiparametric Magnetic Resonance Imaging	Undergo mpMRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2021-02-15
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2021-02-12
• Last updated: 2024-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study