AIMN Multicenter Study: Staging of Lymphomas Using PET/CT

December 11, 2023 updated by: Chiti Arturo, IRCCS San Raffaele

In recent years, the introduction of PET/CT tomographs (which have now almost completely replaced tomographs equipped with PET alone), has allowed a significant increase in diagnostic accuracy in the majority of tumors. However, in order to reduce the radiation doses, administering CT images are acquired for patients at a low dose (generally 60mA 120kV) without the use of contrast agents. This prudential attitude, however, makes it essential to carry out "diagnostic" CT investigations which, at the end of the diagnostic process It leads to an increase in the dose administered for the patient rather than to savings.

This study aims to evaluate the possible advantages in diagnostic, economic and quality of life terms of PET/CT performed with diagnostic CT with intravenous contrast medium, with the aim of benefiting the neoplastic patient in the diagnostic process by optimizing (from a temporal and dosimetric point of view ) the diagnostic procedures to which it is subjected.

It is expected that the integrated PET/CT procedure can facilitate the process of staging the neoplasm and that this procedure can have a positive impact on the patient's quality of life while also reducing the costs incurred in terms of time and money.

Study Overview

Status

Completed

Conditions

Lymphoma

Intervention / Treatment

Diagnostic test: Diagnostic accuracy

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Milano, Italy
    - IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients with malignant lymphoma subjected to diagnostic examination by PET/CT with contrast medium in a single session, instead of on two different dates, as occurs in normal clinical practice.

Description

Inclusion Criteria:

Established lymphoma (non-Hodgkin's lymphoma and Hodgkin's disease) being staged;
Performing the PET/CT examination within two weeks of diagnosis and before treatment;
Signing of the Informed Consent.

Exclusion Criteria:

patients <18 years;
Patients who have not signed the Informed Consent;
Execution of previous anti-inflammatory or anti-inflammatory therapies in the 4 weeks preceding the PET exam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PET/CT with contrast medium in a single session to diagnosis of patients with malignant limphoma. Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2009

Primary Completion (Actual)

February 24, 2011

Study Completion (Actual)

February 24, 2011

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)