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(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
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 18, 2002
    Last Updated
    January 20, 2009
    Sponsor
    US Department of Veterans Affairs
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    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

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    (PET) Imaging in the Management of Patients With Solitary Pulmonary Nodules

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