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
-
-
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.
|
Given IV
Undergo fluorine F 18 d-FMAU PET/CT scan
Other Names:
Undergo fluorine F 18 d-FMAU PET/CT scan
Other Names:
|
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.
Collaborators
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.