Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635837
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation of the Role of Magnetic Resonance Imaging in Ovarian Masses During Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROM-P
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None