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
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
DRUG18F-FMAU
Given IV
Undergo mpMRI
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic fluorine F 18 (18F)-FAMU (FMAU) positron emission tomography (PET) kinetic analysis parameters | Up to 1 year | 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. |
| Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters | Up to 1 year | 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. |
Countries
United States
Outcome results
None listed