Ovarian CancerPROM-PNCT06635837
Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with US-indeterminate adnexal masses detected during pregnancy
Who may be able to join
- 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
Who cannot join
- Patients lacking or with low quality MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Camilla Panico, +39 0630156054, camilla.panico@policlinicogemelli.it
About this study
Official title: Prospective Evaluation of the Role of Magnetic Resonance Imaging 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.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy of MRI.
Evaluate the accuracy of MRI in discriminating benign versus malignant adnexal masses detected during pregnancy, by using subjective assessment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Panico, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635837
- Sponsor's protocol ID
- 6886
- Acronym
- PROM-P
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
- ClinicalTrials.gov ID
- NCT06635837
- Acronym / sponsor ID
- PROM-P / 6886
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with US-indeterminate adnexal masses detected during pregnancy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients lacking or with low quality MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camilla Panico principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Panico, MD (+390630156054, camilla.panico@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the accuracy of MRI. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.