AIMN Multicenter Study: Staging of Lymphomas Using PET/CT

NCT06179693 | Completed

• 1 other identifier: 34/2008/O/OSS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• PET/CT with contrast medium in a single session to diagnosis of patients with malignant limphoma.

  2 years

Interventions

Diagnostic accuracy DIAGNOSTIC_TEST

As per standard procedure, patients will undergo FDG PET. Following the PET exam it will be acquired a standard CT with intravenous contrast medium, using the CT tomograph inserted inside the PET one.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 22, 2023
• Study Start: October 7, 2009
• Primary Completion: February 24, 2011
• Study Completion: February 24, 2011
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)