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

University of Southern California

Status

Terminated

Conditions

Malignant Neoplasm

Treatments

Radiation: fluorine F 18 d-FMAU

Procedure: positron emission tomography

Procedure: computed tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02079181

NCI-2014-00314 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

0S-12-3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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