Trial record 1 of 1 for:    NCT02079181
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18F-FMAU PET/CT in Imaging Patients With Advanced Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT02079181
First received: March 3, 2014
Last updated: March 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Malignant Neoplasm
Radiation: fluorine F 18 d-FMAU
Procedure: positron emission tomography
Procedure: computed tomography
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 18F-FMAU for Imaging in Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Radiation dosimetry of fluorine F 18 d-FMAU [ Time Frame: Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo fluorine F 18 d-FMAU PET/CT scan
Other Name: tomography, computed

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079181

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Bhushan S. Desai    323-652-0343    bhushand@usc.edu   
Principal Investigator: Peter S. Conti         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Peter Conti University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02079181     History of Changes
Other Study ID Numbers: 0S-12-3, NCI-2014-00314, 0S-12-3, P30CA014089
Study First Received: March 3, 2014
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neoplasms
Fluorides
Clevudine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014