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

Glioma Clinical Trial

Official title:

Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752267
• Other study ID #: 6B-20-1
• Secondary ID: NCI-2021-007066B
• Status: Completed
• Phase: Early Phase 1
• Start date: February 15, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage IV Breast Cancer AJCC v8
• Brain Neoplasms
• Breast Neoplasms
• Carcinoma
• Carcinoma, Renal Cell
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Colonic Neoplasms
• Glioma
• Kidney Neoplasms
• Lung Neoplasms
• Malignant Brain Neoplasm
• Melanoma
• Metastatic Breast Carcinoma
• Metastatic Colon Carcinoma
• Metastatic Kidney Carcinoma
• Metastatic Lung Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Melanoma
• Neoplasms
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Skin Neoplasms
• 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

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT

Drug:
• 18F-FMAU
Given IV

Procedure:
• Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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