NCT06635837 Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
| NCT ID | NCT06635837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-10-01 with a primary completion date of 2028-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Camilla Panico
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06635837 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06635837 currently recruiting?
Yes, NCT06635837 is actively recruiting participants. Contact the research team at camilla.panico@policlinicogemelli.it for enrollment information.
Where is the NCT06635837 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06635837 clinical trial?
NCT06635837 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Camilla Panico at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 60 participants.
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