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

NCT04752267 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: 6B-20-1NCI-2021-00706P30CA014089
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

EXPERIMENTAL

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; Drug: 18F-FMAU; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

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

18F-FMAU DRUG

Given IV

Also known as: Fluorine F 18 d-FMAU

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

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo mpMRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

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

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give consent
• Inability to remain motionless during imaging studies
• Intractable seizures
• Claustrophobia
• Implantable devices incompatible with magnetic resonance (MR) environment

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Breast Neoplasms; Colonic Neoplasms; Carcinoma, Renal Cell; Lung Neoplasms; Melanoma

Interventions

clevudine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Adenocarcinoma; Carcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hossein Jadvar, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: February 15, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (1)