Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.

Gynecological cancers involve several tumors of the female reproductive system. The five most common gynecological tumors are those of the uterine cervix, endometrium, ovary, vagina and vulva. Furthermore, although rarer, there is a further gynecological tumor, which is generated from the gestational trophoblast tissue.These pathologies represent an important burden for society since there are over nine hundred thousand cases in Europe.

Ultrasound examination is the investigation commonly used to monitor high-risk women.

Magnetic resonance imaging (MRI) is considered the most accurate imaging technique for presurgical staging of gynecological tumors. Computed tomography (CT), on the other hand, is not usually used for diagnosis, but is considered very useful for investigating possible distant metastases.Finally, integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting, including gynecological malignancies.

The present study is of considerable clinical relevance as at our Institute it is possible to have a significant number of patients suffering from gynecological neoplastic pathologies that are studied using PET, thus allowing the identification and validation of innovative imaging biomarkers, with the use of both traditional imaging parameters and radiomic features.

Study Overview

• Status: Recruiting
• Conditions: Gynecological Tumors
• Intervention / Treatment: Diagnostic test: the diagnostic and prognostic value of PET/MRI and PET/CT with 18F-FDG in patients presenting with gynecological tumors

• Study Type: Observational
• Enrollment (Estimated): 380

Contacts and Locations

• Study Contact: Name: Arturo Chiti; Phone Number: 0226432716; Email: chiti.arturo@hsr.it
• Study Contact Backup: Name: Alessandra Maielli; Phone Number: 0226432716; Email: maielli.alessandra@hsr.it

Study Locations

• Italy
  • Italia
    • Milano, Italia, Italy
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Alessandra Maielli; Phone Number: 0226432716; Email: maielli.alessandra@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

In this study, all patients referred to the gynecology oncology unit of the IRCCS San Raffaele from 01/01/2009 to July 2021 who underwent a PET examination with 18 F FDG at the unit of Nuclear Medicine at the IRCCS San Raffaele for clinical reasons will be considered.

Description

Inclusion Criteria:

• adult patients suffering from a gynecological oncological disease; Patients who have performed at least one PET study with 18F FDG for the staging or restaging of their oncological pathology; patients who give written informed consent to the study

Exclusion Criteria:

• patients <18 years lack of availability of clinical and PET imaging data useful for analyses.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET/MRI and PET/CT with 18F-FDG in patients with gynecological tumors.	Integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques are able to provide information in predicting and explaining histological data in gynecological tumors.	3 year

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): December 27, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: PET-GYN-Retrospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No