An interventional study of fluorine F 18 d-FMAU and positron emission tomography in Malignant Neoplasm, sponsored by University of Southern California. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by University of Southern California · Not applicable, Interventional, and Diagnostic
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
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 · Procedure: positron emission tomography · Procedure: computed tomography
Given IV
Undergo fluorine F 18 d-FMAU PET/CT scan
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Undergo fluorine F 18 d-FMAU PET/CT scan
Also known as: tomography, computed
Radiation dosimetry of fluorine F 18 d-FMAU
Time frame: 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
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
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Southern California