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

Recruiting

• Conditions: Gynecological Tumors

• Registration Number: NCT06159907
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 380

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PET/MRI and PET/CT with 18F-FDG in patients with gynecological tumors.	3 year	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.

Trial Locations

Locations (1)

Irccs San Raffaele; 🇮🇹 Milano, Italia, Italy