- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168877
Use of Integrated PET/CT as a First Line Staging and Re-staging Technique in Oncologic Patient.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with contraindications to performing investigations with contrast medium.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET/TC and TCMDC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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