Benign and Malignant Solitary Pulmonary Nodules Clinical Trial
Official title:
18/F-FLUORODEOXYGLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY (PET) IMAGING IN THE MANAGEMENT OF PATIENTS WITH SOLITARY PULMONARY NODULES
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).
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic