Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors
| Registry | NCT04752267 |
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| Status | Completed |
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| Phase | Early Phase 1 |
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| Study type | Interventional; na, single group, masking: none, diagnostic |
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| Enrollment | 10 (Actual) |
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| Sponsor | University of Southern California (Other); collaborators: National Cancer Institute (NCI) |
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| 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 |
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| Interventions | Computed Tomography, 18F-FMAU, Multiparametric Magnetic Resonance Imaging, Positron Emission Tomography (Procedure, drug) |
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| Dates | start 2021-02-15, primary completion 2023-09-18, completion 2023-09-18, first posted 2021-02-12, last updated 2024-05-24 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Anatomic Stage IV Breast Cancer AJCC v8 All trials for Clinical Stage IV Cutaneous Melanoma AJCC v8 All trials of Computed Tomography All trials of 18F-FMAU
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Diagnostic (18F-FMAU, PET/CT, mpMRI) | Experimental | Procedure: Computed Tomography; Drug: 18F-FMAU; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography | 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. |
- Computed Tomography (Procedure), also known as CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography: Undergo PET/CT
- 18F-FMAU (Drug), also known as Fluorine F 18 d-FMAU: Given IV
- Multiparametric Magnetic Resonance Imaging (Procedure), also known as MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI: Undergo mpMRI
- Positron Emission Tomography (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging: Undergo PET/CT
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| USC / Norris Comprehensive Cancer Center | Los Angeles, California | United States | |
+Investigators
+Funding