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(PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules Clinical research trials and (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules. (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules clinical trial. Test subjects typically receive the most expert healthcare available for their (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "(" Clinical Trials Conditions > (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules  (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules
(PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules
For Condition: Benign and malignant solitary pulmonary nodules
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 500
Location and Contact Information:
Additional Information:
Study ID Numbers: 27;
Study Start Date: January 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032331
Other Benign And Malignant Solitary Pulmonary Nodules Studies:
1. (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules
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Other Benign and malignant solitary pulmonary nodules Clinical Trials
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(PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules
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