Back to resultsMRI in Ovarian Tumors
Primary Purpose
Ovarian Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria: females with ovarian masses - Exclusion Criteria: females with known benign ovarian masses
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
female with ovarian masses
Arm Description
MRI with contrast according to the kidney function test of the patients
Outcomes
Primary Outcome Measures
MRI in ovarian tumors
Role of parametric MRI in determint ovarian lesions by using ORADS MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT05769205
First Posted
February 26, 2023
Last Updated
March 3, 2023
Sponsor
Assiut University
Collaborators
principle investigator
1. Study Identification
Unique Protocol Identification Number
NCT05769205
Brief Title
MRI in Ovarian Tumors
Official Title
Role of Multi Paramertic MRI and MRI Perfusion in Indetermint Ovarian Lesions by Using ORADS MRI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
principle investigator
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI
Detailed Description
Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
females with ovarian masses
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
female with ovarian masses
Arm Type
Experimental
Arm Description
MRI with contrast according to the kidney function test of the patients
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI with contrast
Primary Outcome Measure Information:
Title
MRI in ovarian tumors
Description
Role of parametric MRI in determint ovarian lesions by using ORADS MRI
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Ovaries lesions
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: females with ovarian masses
-
Exclusion Criteria:
females with known benign ovarian masses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Farouk Sayed
Phone
01064353498
Email
Faroukmariam54@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Hashem
Email
hashemradiol@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35059059
Citation
Patel RK, Garg A, Dixit R, Gandhi G, Khurana N. The role of "penumbra sign" and diffusion-weighted imaging in adnexal masses: do they provide a clue in differentiating tubo-ovarian abscess from ovarian malignancy? Pol J Radiol. 2021 Dec 15;86:e661-e671. doi: 10.5114/pjr.2021.111986. eCollection 2021.
Results Reference
background
Learn more about this trial
MRI in Ovarian Tumors
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