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OpenTrials
Completed

NCT Number: NCT01502670

Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule

This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be 18 years of age or older.
  • Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
  • Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent.

Exclusion criteria

  • Age less than 18.
  • Active carcinoma with known metastatic disease.
  • Size of primary lesion less than 1 cm or greater than 3 cm
  • Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
  • Inability to lie still for PET scanning
  • Cannot provide written informed consent

Treatment and study plan

18F-FACBC Radiotracer

Drug

Test radiotracer uptake in lung nodule

Other names: Radiotracer

Primary outcomes

  1. Correlation of Radiotracer Uptake with Histology

    Time frame: Typically 1-2 months

    We will correlate radiotracer uptake with histology results

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Nihon Medi-Physics Co., Ltd.

Registry information

Official study title

A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules

Acronym: SPN

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 2, 2012
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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