Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule
SPN
A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lung-cancer
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedNovember 19, 2013
November 1, 2013
3.1 years
December 21, 2011
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation of Radiotracer Uptake with Histology
We will correlate radiotracer uptake with histology results
Typically 1-2 months
Study Arms (1)
Lung Nodule
EXPERIMENTALInterventions
Test radiotracer uptake in lung nodule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Nihon Medi-Physics Co., Ltd.collaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 23595643RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2011
First Posted
January 2, 2012
Study Start
May 1, 2009
Primary Completion
June 1, 2012
Study Completion
January 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11