Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032331
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-03-18
Brief Title:
PET Imaging in the Management of Patients With Solitary Pulmonary Nodules
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
18F-FLUORODEOXYGLUCOSE FDG POSITRON EMISSION TOMOGRAPHY PET IMAGING IN THE MANAGEMENT OF PATIENTS WITH SOLITARY PULMONARY NODULES
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None