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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06159907
Enrollment
380
Registered
2023-12-07
Start date
2021-10-27
Completion date
2024-12-27
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Tumors

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.

Interventions

DIAGNOSTIC_TESTthe 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

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
PET/MRI and PET/CT with 18F-FDG in patients with gynecological tumors.3 yearIntegrated 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.

Countries

Italy

Contacts

Primary ContactArturo Chiti
chiti.arturo@hsr.it0226432716
Backup ContactAlessandra Maielli
maielli.alessandra@hsr.it0226432716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026