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

NCT ID: NCT01502670

Last Updated: 2013-11-19

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Keywords

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Pulmonary nodules

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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Lung Nodule

Group Type EXPERIMENTAL

18F-FACBC Radiotracer

Intervention Type DRUG

Test radiotracer uptake in lung nodule

Interventions

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18F-FACBC Radiotracer

Test radiotracer uptake in lung nodule

Intervention Type DRUG

Other Intervention Names

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Radiotracer

Eligibility Criteria

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Inclusion Criteria

1. Patients must be 18 years of age or older.
2. 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).
3. 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.
4. Ability to lie still for PET scanning
5. Patients must be able to provide written informed consent.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon Medi-Physics Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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David M. Schuster, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Amzat R, Taleghani P, Miller DL, Beitler JJ, Bellamy LM, Nye JA, Yu W, Savir-Baruch B, Osunkoya AO, Chen Z, Auffermann WF, Goodman MM, Schuster DM. Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Mol Imaging Biol. 2013 Oct;15(5):633-43. doi: 10.1007/s11307-012-0606-7.

Reference Type RESULT
PMID: 23595643 (View on PubMed)

Other Identifiers

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14701

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00006621

Identifier Type: -

Identifier Source: org_study_id