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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2023-08-22

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.

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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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fluorine F 18 d-FMAU

Intervention Type RADIATION

Given IV

positron emission tomography

Intervention Type PROCEDURE

Undergo fluorine F 18 d-FMAU PET/CT scan

computed tomography

Intervention Type PROCEDURE

Undergo fluorine F 18 d-FMAU PET/CT scan

Interventions

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fluorine F 18 d-FMAU

Given IV

Intervention Type RADIATION

positron emission tomography

Undergo fluorine F 18 d-FMAU PET/CT scan

Intervention Type PROCEDURE

computed tomography

Undergo fluorine F 18 d-FMAU PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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FDG-PET PET PET scan tomography, emission computed tomography, computed

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No