Lung CancerNCT06168877
Use of Integrated PET/CT as a First Line Staging and Re-staging Technique in Oncologic Patient.
An observational study of Lung Cancer, run by IRCCS San Raffaele.
Trial summary
Positron emission tomoscintigraphy (PET) and contrast computed tomography (CTmdc) are diagnostic methods widely used in the staging and restaging of neoplastic diseases. In recent years, PET tomographs have been implemented, integrating a CT scanner into the PET tomograph (PET/CT): these tomographs are able to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Execution of 18F-FDG PET/CT and contrast-enhanced CT scan.
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2009to 3 Jul 2014
- 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
- Adult, Older adult
Study population: patients suffering from lymphoma or lung cancer undergoing PET/CT and contrast-enhanced CT in a single examination session.
Who may be able to join
- patients suffering from lung cancer or lymphoma in which the two diagnostic investigations mentioned (PET and contrast-enhanced CT) are part of the routine diagnostic-therapeutic program of the disease in question;
- Patients suffering from lung cancer will be in the stage of primary neoplasm staging;
- Patients suffering from lymphoma will be evaluated both in the disease staging phase at onset and re-evaluation after radio-chemotherapy treatment.
Who cannot join
- Patients with contraindications to performing investigations with contrast medium.
About this study
Positron emission tomoscintigraphy (PET) and contrast computed tomography (CTmdc) are diagnostic methods widely used in the staging and restaging of neoplastic diseases. In recent years, PET tomographs have been implemented, integrating a CT scanner into the PET tomograph (PET/CT): these tomographs are able to simultaneously acquire the function/metabolism study (PET) and the morgfostructural study (CT).
Numerous clinical studies have demonstrated the added diagnostic value of PET/CT compared to PET with consequent effect on the choice of treatment type. In addition to the potential clinical value deriving from the simultaneous execution of the two diagnostic methods, it is necessary to consider the possibility of a reduction in indirect costs deriving from the reduction of days of work lost and costs related to transport, both for the patient and for any companions.
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The aims of this multicenter observational study are:
- evaluate the diagnostic accuracy of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer).
- evaluate any psychological, quality of life and economic benefits deriving from carrying out the two diagnostic procedures in a single examination session.
- Conditions
- Lung Cancer
- Being tested
- Execution of 18F-FDG PET/CT and contrast-enhanced CT scan.
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Execution of 18F-FDG PET/CT and contrast-enhanced CT scan.Diagnostic test
PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer).
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients.
Use of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients in terms of diagnostic accuracy, quality of life and economic aspects.
Measured: 5 years
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 start21 Oct 2009
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- 30 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
- NCT06168877
- Sponsor's protocol ID
- PET/TC and TCMDC
- 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
- Use of Integrated PET/CT as a First Line Staging and Re-staging Technique in Oncologic Patient.
- ClinicalTrials.gov ID
- NCT06168877
- Acronym / sponsor ID
- PET/TC and TCMDC
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 21 Oct 2009 (actual)
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (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.
Positron emission tomoscintigraphy (PET) and contrast computed tomography (CTmdc) are diagnostic methods widely used in the staging and restaging of neoplastic diseases. In recent years, PET tomographs have been implemented, integrating a CT scanner into the PET tomograph (PET/CT): these tomographs are able to simultaneously acquire the function/metabolism study (PET) and the morgfostructural study (CT).
Numerous clinical studies have demonstrated the added diagnostic value of PET/CT compared to PET with consequent effect on the choice of treatment type. In addition to the potential clinical value deriving from the simultaneous execution of the two diagnostic methods, it is necessary to consider the possibility of a reduction in indirect costs deriving from the reduction of days of work lost and costs related to transport, both for the patient and for any companions.
The aims of this multicenter observational study are:
- evaluate the diagnostic accuracy of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer).
- evaluate any psychological, quality of life and economic benefits deriving from carrying out the two diagnostic procedures in a single examination session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients suffering from lymphoma or lung cancer undergoing PET/CT and contrast-enhanced CT in a single examination session.
Key inclusion criteria (3 listed)
- patients suffering from lung cancer or lymphoma in which the two diagnostic investigations mentioned (PET and contrast-enhanced CT) are part of the routine diagnostic-therapeutic program of the disease in question;
- Patients suffering from lung cancer will be in the stage of primary neoplasm staging;
- Patients suffering from lymphoma will be evaluated both in the disease staging phase at onset and re-evaluation after radio-chemotherapy treatment.
Key exclusion criteria (1 listed)
- Patients with contraindications to performing investigations with contrast medium.
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 |
|---|---|---|
| Execution of 18F-FDG PET/CT and contrast-enhanced CT scan.PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session (single staging) in cancer patients (patients suffering from lymphoma and lung cancer). | Diagnostic test | – |
Primary outcome
Use of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients.
Time frame: 5 years
Use of PET/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients in terms of diagnostic accuracy, quality of life and economic aspects.
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 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 3 inclusion and 1 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/CT, contrast-enhanced CT and contrast-enhanced PET/CT+CT performed in a single examination session in cancer patients. (time frame: 5 years). 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; AzTrials last refreshed its copy on 6 Nov 2026.