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

NCT06159907 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 380

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Gynecological Tumors

Interventions

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

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2024-12-27
Completion
2024-12-27

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159907 on ClinicalTrials.gov