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

Malignant Neoplasm Clinical Trial

Official title:

18F-FMAU for Imaging in Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02079181
• Other study ID #: 0S-12-3
• Secondary ID: NCI-2014-003140S
• Status: Terminated
• Phase: N/A
• Start date: January 31, 2014
• Est. completion date: August 22, 2023

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Radiation:
• fluorine F 18 d-FMAU
Given IV

Procedure:
• positron emission tomography
Undergo fluorine F 18 d-FMAU PET/CT scan
• computed tomography
Undergo fluorine F 18 d-FMAU PET/CT scan

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