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

University of Southern California

Status and phase: Completed; Early Phase 1

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

Treatments: Procedure: Multiparametric Magnetic Resonance Imaging; Drug: 18F-FMAU; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04752267

6B-20-1 (Other Identifier)

NCI-2021-00706 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Diagnostic (18F-FMAU, PET/CT, mpMRI)

Experimental group

Description:

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.

Treatment:

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Drug: 18F-FMAU

Procedure: Multiparametric Magnetic Resonance Imaging