Clinical trial NCT04752267: 18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases
Official title: Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic fluorine F 18 (18F)-FAMU (FMAU) positron emission tomography (PET) kinetic analysis parameters
timeFrame: Up to 1 year
measure: Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Hossein Jadvar, MD
role: PRINCIPAL_INVESTIGATOR
References: