Benign and Malignant Solitary Pulmonary NodulesPhase 3NCT00032331
(PET) Imaging in the Management of Patients With Solitary Pulmonary Nodules
A Phase 3 study testing PET Imaging and CT scan in people with Benign and Malignant Solitary Pulmonary Nodules, run by US Department of Veterans Affairs.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Benign and Malignant Solitary Pulmonary Nodules
- What is being tested?
- PET Imaging and CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jun 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
About this study
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).
Read the 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.
- Being tested
- PET Imaging, CT scan
- Keywords
- PET imaging, benign and malignant solitary pulmonary nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ImagingProcedure or surgery
CT scanProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2002 (estimated)
- Study startJan 1999
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign and Malignant Solitary Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032331
- Sponsor's protocol ID
- 27
- Status last verified
- Jan 2004
- First submitted
- 18 Mar 2002
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18/F-FLUORODEOXYGLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY (PET) IMAGING IN THE MANAGEMENT OF PATIENTS WITH SOLITARY PULMONARY NODULES
- ClinicalTrials.gov ID
- NCT00032331
- Acronym / sponsor ID
- 27
- Keywords
- PET imaging, benign and malignant solitary pulmonary nodules
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 1999
- Study completion
- Jun 2003
- First posted
- 19 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET Imaging | Procedure or surgery | – |
| CT scan | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
Related trials for Benign and Malignant Solitary Pulmonary Nodules
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
RecruitingObservational study
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary
Not yet recruitingPhase 3
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
Solitary Pulmonary Nodule, Oncology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET Imaging and CT scan in people with Benign and Malignant Solitary Pulmonary Nodules, run by US Department of Veterans Affairs.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.