18F-FMAU PET/CT in Imaging Patients With Advanced Cancers

May 22, 2024 updated by: University of Southern California

18F-FMAU for Imaging in Cancer Patients

This clinical trial studies the safety and drug distribution of the radioactive drug, 2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in patients with advanced cancers. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find out how far the disease has spread.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18F-FMAU for PET imaging, and characterize the incidence of circulating metabolites of 18F-FMAU in humans.

II. To simply find out whether there is any visual uptake change of 18F-FMAU in tumors post-therapy.

OUTLINE:

Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

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

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma
  • Have one or more tumors visualized by conventional PET-CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET-CT should be within one week prior to 18F-FMAU

Exclusion Criteria:

  • Have undergone chemotherapy or radiation therapy within the previous one month
  • Women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betaHCG) within the previous 24 hours of the procedure
  • Patients who have had surgery at the site of the suspected lesion within 1 month

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 (fluorine F 18 d-FMAU PET/CT scan)
Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.
Radiation: fluorine F 18 d-FMAU
Given IV
Procedure: positron emission tomography
Undergo fluorine F 18 d-FMAU PET/CT scan
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo fluorine F 18 d-FMAU PET/CT scan
Other Names:
  • tomography, computed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiation dosimetry of fluorine F 18 d-FMAU
Time Frame: Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Adverse events after injection of fluorine F 18 d-FMAU to the patients
Time Frame: Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Fluorine F 18 d-FMAU uptake change in tumors post-therapy
Time Frame: Baseline up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
Baseline up to 24 hours after fluorine F 18 d-FMAU PET/CT scan

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: Peter Conti, 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)

January 31, 2014

Primary Completion (Actual)

August 22, 2023

Study Completion (Actual)

August 22, 2023

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimated)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0S-12-3 (Other Identifier: USC Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2014-00314 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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