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RECRUITING
NCT06635837

Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Ovarian cancer represents 7% of all cancers in pregnant women. Characterizing an ovarian mass during pregnancy is essential to avoid unnecessary treatment and if treatment is required, to plan it accordingly. Ultrasound is the first line modality in these patients and various tools such as IOTA and ADNEX have been validated in non-pregnant patients to accurately categorize ovarian masses according to their malignant potential. A prospective multicentre study, in which Fondazione Policlinico Gemelli is involved, is currently ongoing aiming to validate these tools in pregnant Patients (p-IOTA). Given the high contrast resolution and the absence of ionizing radiation, Magnetic Resonance Imaging is the preferred second-line modality. It increases the positive predictive value (PPV) of US from 7-50% to 70%, demonstrating a negative predictive value (NV) of 98%. In non-pregnant women, the Ovarian-Adnexal Reporting and Data System-MRI (ORADS-MRI) risk stratification system and the Non-Contrast MRI Score (NCMS) are commonly employed to assess the risk of malignancy in adnexal lesions with accuracies of 92% and 94%, respectively. Recently, both scoring systems have proven effective in retrospectively stratifying benign and malignant adnexal masses in pregnant women.

Official title: Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-10-01

Completion Date

2029-09-30

Last Updated

2025-03-12

Healthy Volunteers

No

Conditions

Locations (1)

Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy