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NCT Number: NCT06635837

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Camilla Panico

CONTACT

[email protected]

+39 0630156054

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the accuracy of MRI.

    Time frame: 5 years

    Evaluate the accuracy of MRI in discriminating benign versus malignant adnexal masses detected during pregnancy, by using subjective assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Panico, MD

CONTACT

[email protected]

+390630156054

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PROM-P

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Oct 10, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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