AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT06168916
• Lead Sponsor: IRCCS San Raffaele

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-14
• Primary Completion: 2010-11-11
• Study Completion: 2010-11-11
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients with histologically proven NSCLC, undergoing staging or restaging;
• plasma creatinine normal;

Exclusion Criteria

• patients with lung microcytoma;
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of PET and CT with contrast in a single session	1 year	In patients with confirmed NSCLC, evaluate the diagnostic accuracy of low dose PET-CT and contrast-enhanced PET CT