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

Gynecological Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159907
• Other study ID #: PET-GYN-Retrospective
• Status: Recruiting
• Start date: October 27, 2021
• Est. completion date: December 27, 2024

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Arturo Chiti
• Phone: 0226432716
• Email: chiti.arturo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 27, 2024
• Est. primary completion date: December 27, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecological Tumors

Intervention

Diagnostic Test:
• the diagnostic and prognostic value of PET/MRI and PET/CT with 18F-FDG in patients presenting with gynecological tumors
For the evaluation of patients affected by endometrial cancer, the correlations between semi-quantitative PET parameters (SUVmax, SUVmean, MTV and TLG calculated at different SUVmax thresholds) and histological data, such as for example myometrial invasion, will be investigated. lymph node invasion, tumor grade and type, risk level, probability of mutation of the p53 gene, etc. In addition to traditional imaging parameters we will also investigate the usefulness of radiomic features, i.e. quantitative data extracted from PET images (PET/CT or PET/MRI), in predicting and explaining histological data

Locations

Country	Name	City	State
Italy	Irccs San Raffaele	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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