Actively Recruiting
Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-12
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant patients over 18 years old
- Ability to understand and sign informed consent
- Presence of adnexal mass with multilocular morphology or solid component detected by ultrasound during pregnancy
- Availability of MRI imaging using 1.5T or 3.0T scanners
- Availability of histopathological reports during pregnancy or within 3 months after delivery, or at least one ultrasound follow-up 6-12 months after MRI
You will not qualify if you...
- Patients with missing or low-quality MRI scans
AI-Screening
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Trial Site Locations
Total: 1 location
1
Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
C
Camilla Panico, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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