Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168, Italy
Location status: Recruiting
NCT Number: NCT06635837
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Rome, 00168, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years
Evaluate the accuracy of MRI in discriminating benign versus malignant adnexal masses detected during pregnancy, by using subjective assessment.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
Acronym: PROM-P
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.
Published trials that share one or more normalized conditions with this study.
NCT07539844
Adnexal Diseases, Endocrine Gland Neoplasms
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
View Trial DetailsNCT07059845
Adnexal Diseases, Endocrine Gland Neoplasms
La Jolla, California, United States
View Trial DetailsNCT04657068
Acinar Cell Carcinoma, Adenocarcinoma
Birmingham, Alabama, United States
View Trial DetailsNCT03877796
Adnexal Diseases, Endocrine Gland Neoplasms
Tampa, Florida, United States
View Trial Details