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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors

Conditions
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Glioma, Stage IVA Colon Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, 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 IVB Colon Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: 18F-FMAU
* Procedure: Multiparametric Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (18F-FMAU, PET/CT, mpMRI)<br>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. | Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Drug: 18F-FMAU<br>* Given IV<br>* Other names: Fluorine F 18 d-FMAU;Procedure: Multiparametric Magnetic Resonance Imaging<br>* Undergo mpMRI<br>* Other names: Multiparametric MRI;Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic fluorine F 18 (18F)-FAMU (FMAU) positron emission tomography (PET) kinetic analysis parameters | Scatter plots will be used to illustrate the pattern of correlation. For normality distributed data, Pearson correlation will be used; otherwise, Spearman correlation will be used. There will be 90 pairs of correlations. To further confirm the robustness of the correlation finding, the Benjamini-Hochberg procedure will be applied to prevent false discovery. | Up to 1 year | 
| Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters | Interesting patterns will be observed at individual subject level for the difference between presence or absence of recurrent tumor, which defined as either underlying immunohistochemistry (Ki67-MIB proliferation marker, when tissue sample is available, or a binary proxy marker of subsequent clinical management decision (with wait-and-watch strategy for 1 month after imaging studies considered as absence of recurrent tumor, otherwise marked as presence of recurrent tumor). Heatmap will be used with subject identification as x-axis and each radiomic/kinetic feature as y-axis. Features will be divided by categories to facilitate the visualization of patterns. | Up to 1 year |