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

March 14, 2024 updated by: University of Southern California

Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (18F-FMAU, PET/CT, mpMRI)
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
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • Multiparametric MRI
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
Drug: 18F-FMAU
Given IV
Other Names:
  • Fluorine F 18 d-FMAU

What is the study measuring?

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
Time Frame: 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.
Up to 1 year
Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters
Time Frame: 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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Hossein Jadvar, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6B-20-1 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2021-00706 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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