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

Status: Temporarily Closed to Accrual

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

Los Angeles
Los Angeles County-USC Medical Center
Status: Temporarily closed to accrual
Contact: Rosaura Diaz-Navarro
Phone: 323-442-7469
Email: rosaura.diaz@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Peter Stephen Conti
Phone: 323-442-3216
Email: pconti@usc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the radiation dosimetry of 18F-FMAU in humans, confirm absence of adverse events in humans from intravenous (iv) 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 over 1 minute 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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Diagnostic

Lead Organization

Lead Organization
USC / Norris Comprehensive Cancer Center

Principal Investigator
Peter Stephen Conti

Trial IDs

Primary ID 0S-12-3
Secondary IDs NCI-2014-00314
Clinicaltrials.gov ID NCT02079181