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

Not Applicable

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Radiation: fluorine F 18 d-FMAU; Procedure: positron emission tomography; Procedure: computed tomography

• Registration Number: NCT02079181
• Lead Sponsor: University of Southern California

Brief 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.

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 Timeline

• Study Start: 2014-01-31
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Status Verified: 2023-08
• Primary Completion: 2023-08-22
• Study Completion: 2023-08-22
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluorine F 18 d-FMAU PET/CT scan)	fluorine F 18 d-FMAU	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.
Diagnostic (fluorine F 18 d-FMAU PET/CT scan)	positron emission tomography	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.
Diagnostic (fluorine F 18 d-FMAU PET/CT scan)	computed tomography	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.

Primary Outcome Measures

Name	Time	Method
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
Radiation dosimetry of fluorine F 18 d-FMAU	Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan
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

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States