Evaluating MRI for ovarian masses in pregnant women
Official title: Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06635837 · Data updated 2026-11-12
This study is testing whether MRI can help doctors better understand ovarian masses in pregnant women to improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | August 30, 2028 |
| Study ends | September 30, 2029 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06635837 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women over 18 years old with an adnexal mass detected during pregnancy.
✕Probably not a fit
Patients without an adnexal mass or those with low-quality MRI results may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of Magnetic Resonance Imaging (MRI) in characterizing ovarian masses found during pregnancy. It focuses on pregnant patients with adnexal masses that exhibit multilocular morphology or solid components as detected by ultrasound. The study will validate existing risk stratification tools, such as the Ovarian-Adnexal Reporting and Data System-MRI (ORADS-MRI), specifically in the context of pregnancy. By utilizing MRI, which does not involve ionizing radiation, the study seeks to improve diagnostic accuracy and patient management.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for ovarian masses in pregnant women, leading to better treatment planning and outcomes.
How similar studies have gone: While the use of MRI in non-pregnant women has shown success, this specific application in pregnant patients is novel and under-evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patients \> 18 years old * Ability to understand and sign informed consent * Patient with adnexal mass detected during pregnancy with either multilocular morphology or solid component at ultrasound examination * Availability of MR imaging (1.5T and 3.0T MR scanner) * Availability of histopathological reports obtained during pregnancy or within 3 months from delivery or at least one US follow-up examination 6-12 months after MRI examination Exclusion Criteria: * Patients lacking or with low quality MRI
Where it's running
-
Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy Recruiting
Study contacts
- Principal investigator: Camilla Panico — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Panico, MD
- Email: camilla.panico@policlinicogemelli.it
- Phone: +390630156054
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.