Non Small Cell Lung CancerNCT06168916
AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?
An observational study of Non Small Cell Lung Cancer, run by IRCCS San Raffaele.
Trial summary
Accurate staging of patients with non-small cell cancer (NSCLC) is of fundamental importance both for the correct choice of treatment plan and for prognosis. Numerous studies have demonstrated the added value of co-registration of functional PET images and anatomical CT images using hybrid PET-CT tomographs and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- PET/CT with contrast medium in a single session.
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2009to 11 Nov 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with non-small cell lung cancer undergoing PET and contrast-enhanced CT during staging or restaging.
Who may be able to join
- patients with histologically proven NSCLC, undergoing staging or restaging;
- plasma creatinine normal;
Who cannot join
- patients with lung microcytoma;
- pregnant women
About this study
Accurate staging of patients with non-small cell cancer (NSCLC) is of fundamental importance both for the correct choice of treatment plan and for prognosis. Numerous studies have demonstrated the added value of co-registration of functional PET images and anatomical CT images using hybrid PET-CT tomographs and the consequent benefits on the choice of treatment in patients with NSCLC. Currently in most PET centers CT is performed with a "low dose" technique and is used exclusively as a transmissive source for attenuation correction and anatomical localization. The availability of new generation hybrid tomographs allows for "diagnostic" CT examinations (contrast CT) to be performed with a standard dose of radiation and with the use of intravenous and/or oral iodinated contrast medium (contrast medium). Little data is currently available on the added value of a PET-CT scan performed in a single session compared to PET-CT performed independently and, generally, subsequently to CT scan.
The objective of the study is to evaluate the ability to correctly define the accuracy in localizing and characterizing lung "lesions" in patients with confirmed NSCLC, in the staging or restaging phase, through the use of: PET-CT "low-dose" and PET contrast CT.
The effects of the two procedures on the patient's quality of life and on the costs incurred by the patient and the healthcare service will also be evaluated.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- PET/CT with contrast medium in a single session.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with contrast medium in a single session.Diagnostic test
Patients will undergo low dose PET/CT with FDG. Following the PET exam, a Standard CT with contrast medium will be acquired, using the CT tomography inserted inside the PET.
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of PET and CT with contrast in a single session
In patients with confirmed NSCLC, evaluate the diagnostic accuracy of low dose PET-CT and contrast-enhanced PET CT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start14 Apr 2009
- Primary completion11 Nov 2010
- Study completion11 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168916
- Sponsor's protocol ID
- POLMONE01
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?
- ClinicalTrials.gov ID
- NCT06168916
- Acronym / sponsor ID
- POLMONE01
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 14 Apr 2009 (actual)
- Primary completion
- 11 Nov 2010 (actual)
- Study completion
- 11 Nov 2010 (actual)
- First posted
- 13 Dec 2023 (actual)
- 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.
Accurate staging of patients with non-small cell cancer (NSCLC) is of fundamental importance both for the correct choice of treatment plan and for prognosis. Numerous studies have demonstrated the added value of co-registration of functional PET images and anatomical CT images using hybrid PET-CT tomographs and the consequent benefits on the choice of treatment in patients with NSCLC. Currently in most PET centers CT is performed with a "low dose" technique and is used exclusively as a transmissive source for attenuation correction and anatomical localization. The availability of new generation hybrid tomographs allows for "diagnostic" CT examinations (contrast CT) to be performed with a standard dose of radiation and with the use of intravenous and/or oral iodinated contrast medium (contrast medium). Little data is currently available on the added value of a PET-CT scan performed in a single session compared to PET-CT performed independently and, generally, subsequently to CT scan.
The objective of the study is to evaluate the ability to correctly define the accuracy in localizing and characterizing lung "lesions" in patients with confirmed NSCLC, in the staging or restaging phase, through the use of: PET-CT "low-dose" and PET contrast CT.
The effects of the two procedures on the patient's quality of life and on the costs incurred by the patient and the healthcare service will also be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with non-small cell lung cancer undergoing PET and contrast-enhanced CT during staging or restaging.
Key inclusion criteria (2 listed)
- patients with histologically proven NSCLC, undergoing staging or restaging;
- plasma creatinine normal;
Key exclusion criteria (2 listed)
- patients with lung microcytoma;
- pregnant women
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/CT with contrast medium in a single session.Patients will undergo low dose PET/CT with FDG. Following the PET exam, a Standard CT with contrast medium will be acquired, using the CT tomography inserted inside the PET. | Diagnostic test | – |
Primary outcome
Use of PET and CT with contrast in a single session
Time frame: 1 year
In patients with confirmed NSCLC, evaluate the diagnostic accuracy of low dose PET-CT and contrast-enhanced PET CT
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 13 Dec 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Non Small Cell Lung Cancer, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. 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.
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.
What does the primary outcome measure?
Use of PET and CT with contrast in a single session (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 13 Dec 2023.