(PET) Imaging in the Management of Patients With Solitary Pulmonary Nodules
Primary Purpose
Benign and Malignant Solitary Pulmonary Nodules
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PET Imaging
CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Benign and Malignant Solitary Pulmonary Nodules focused on measuring PET imaging, benign and malignant solitary pulmonary nodules
Eligibility Criteria
All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to participate in the study.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032331
First Posted
March 18, 2002
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00032331
Brief Title
(PET) Imaging in the Management of Patients With Solitary Pulmonary Nodules
Official Title
18/F-FLUORODEOXYGLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY (PET) IMAGING IN THE MANAGEMENT OF PATIENTS WITH SOLITARY PULMONARY NODULES
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to undergo positron emission tomography (PET) and computerized tomography (CT). The PET and CT scans will be interpreted independently.
The Primary Care Physician will be provided the results of the baseline chest x-ray and the CT scan, and will be asked for a management and treatment decision. Then the results of the PET will be provided to the Primary Care Physician who will be asked for a management and treatment decision based on all findings (chest x-ray, CT, and PET).
Detailed Description
Intervention: All patients will undergo a CT scan and PET imaging. Primary Hypothesis: FDG-PET will be more accurate than existing anatomic modalities (chest x-ray and CT scan) in distinguishing between benign and malignant solitary pulmonary nodules (SPN)? This should expedite the removal of any potentially surgically curable malignant lesion and minimize the number of benign masses and surgically incurable lung neoplasms for which unnecessary thoracotomy is done. Secondary Hypothesis: What is the impact of the results of FDG-PET on the diagnosis made and treatment rendered by the referring physicians? What is the intra- and inter-reader reliability of FDG-PET? What is the effect of FDG-PET on the cost of early management of SPNs when FDG-PET is included in the management paradigm or substituted for CT?
Primary Outcomes: Benign or malignant solitary pulmonary nodules, and their treatment.
Study Abstract: All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to participate in the study. Patients will undergo positron emission tomography (PET) and computerized tomography (CT). The PET and CT scans will be interpreted independently.
The Primary Care Physician will be provided the results of the baseline chest x-ray and the CT scan, and will be asked for a management and treatment decision. Then the results of the PET will be provided to the Primary Care Physician who will be asked for a management and treatment decision based on all findings (chest x-ray, CT, and PET).
Site readers will perform an overview of the CT and PET interpretations and provide a diagnosis of the SPN. There will be an Independent Research Readers Panel which will perform an overview of the CT and PET interpretations and provide a diagnosis of the SPN. These readings will determine inter-reader reliability, and those by the Independent Research Readers Panel will be used as the primary diagnostic measure for the sensitivity and specificity analysis.
The CT and PET diagnoses will be compared with the 'gold standard' (tissue diagnosis, either by fine needle biopsy or surgical pathology, or two year follow-up for changes in the SPN on chest x-ray) to construct Receiver Operating Characteristics (ROC) curves.
There are two substudies - one investigating the economic analysis and one investigating the accuracy of coincidence PET scanning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign and Malignant Solitary Pulmonary Nodules
Keywords
PET imaging, benign and malignant solitary pulmonary nodules
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PET Imaging
Intervention Type
Procedure
Intervention Name(s)
CT scan
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to participate in the study.
12. IPD Sharing Statement
Learn more about this trial
(PET) Imaging in the Management of Patients With Solitary Pulmonary Nodules
We'll reach out to this number within 24 hrs