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

Primary Purpose

Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Glioma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
18F-FMAU
Multiparametric Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2021
Last Updated
March 6, 2023
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04752267
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (18F-FMAU, PET/CT, mpMRI)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo PET/CT
Intervention Type
Drug
Intervention Name(s)
18F-FMAU
Other Intervention Name(s)
Fluorine F 18 d-FMAU
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Multiparametric Magnetic Resonance Imaging
Other Intervention Name(s)
MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Intervention Description
Undergo mpMRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT
Primary Outcome Measure Information:
Title
Correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic fluorine F 18 (18F)-FAMU (FMAU) positron emission tomography (PET) kinetic analysis parameters
Description
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.
Time Frame
Up to 1 year
Title
Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossein Jadvar, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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