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:

1. 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).
2. 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: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Execution of 18F-FDG PET/CT and contrast-enhanced CT scan.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

patients suffering from lymphoma or lung cancer undergoing PET/CT and contrast-enhanced CT in a single examination session.

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?

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.	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: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2009
• Primary Completion (Actual): July 3, 2014
• Study Completion (Actual): July 3, 2014

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: PET/TC and TCMDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No