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OpenTrials
Completed

NCT Number: NCT06168916

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with lung microcytoma;
  • pregnant women

Treatment and study plan

PET/CT with contrast medium in a single session.

Diagnostic Test

Patients will undergo low dose PET/CT with FDG. Following the PET exam, a Standard CT with contrast medium will be acquired, using the CT tomography inserted inside the PET.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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