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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06635837

Acronym

PROM-P

Enrollment

Registered

2024-10-10

Start date

2024-10-01

Completion date

2029-09-30

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the accuracy of MRI.	5 years	Evaluate the accuracy of MRI in discriminating benign versus malignant adnexal masses detected during pregnancy, by using subjective assessment.

Countries

Italy

Contacts

Primary ContactCamilla Panico, MD

camilla.panico@policlinicogemelli.it+390630156054

Outcome results