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Clinical Trials/NCT06168916
NCT06168916CompletedNot Applicable

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

IRCCS San Raffaele0 sites14 target enrollmentStarted: April 14, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Primary Endpoint
Use of PET and CT with contrast in a single session

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • patients with lung microcytoma;
  • pregnant women

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chiti Arturo

Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

IRCCS San Raffaele

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