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

Study Overview
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Brief Summary
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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
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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.

Official Title
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18F-FMAU for Imaging in Cancer Patients

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Radiation: fluorine F 18 d-FMAU
* Procedure: positron emission tomography
* Procedure: computed tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention 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)<br>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<br>* Given IV<br>Procedure: positron emission tomography<br>* Undergo fluorine F 18 d-FMAU PET/CT scan<br>* Other names: tomography, emission computed;Procedure: computed tomography<br>* Undergo fluorine F 18 d-FMAU PET/CT scan<br>* Other names: tomography, computed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dosimetry of fluorine F 18 d-FMAU |  | 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 |  | 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 |