Evaluating MRI for ovarian masses in pregnant women
Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome) |
| Trial ID | NCT06635837 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old with an adnexal mass detected during pregnancy.
Not a fit: Patients without an adnexal mass or those with low-quality MRI results may not benefit from this study.
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 performed: While the use of MRI in non-pregnant women has shown success, this specific application in pregnant patients is novel and under-evaluated.
Eligibility criteria
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 this trial is running
Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.