Actively Recruiting
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-15
74
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women with ovarian masses that cannot be clearly identified by ultrasound. The study focuses on evaluating the use of pelvic MRI scans that include special imaging techniques called diffusion- and perfusion-weighted sequences. The goal is to see how well these MRI findings match with tissue analysis or follow-up over two years. Participants will undergo pelvic MRI scans as the main observation in this study. These scans use advanced imaging methods to better characterize the ovarian masses that remain unclear after ultrasound examination. The study mainly involves women who have such undetermined adnexal masses and does not include treatment or placebo groups. During the study, participants will have their MRI results compared with either tissue samples from surgery or clinical follow-up lasting up to two years. Researchers will collect and analyze this information to better understand the diagnostic value of MRI in these cases. The total observation period for each participant may last up to two years to confirm the nature of the ovarian mass.
CONDITIONS
Brief Title
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any woman with an adnexal mass undetermined by gynecological ultrasound
You will not qualify if you...
- Any lesion with definite diagnosis by gynecological ultrasound
- Denial or withdrawal of oral informed consent
- Contra-indication for MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo a pelvic MRI to characterize ovarian masses that could not be classified by gynecological ultrasound.
1 baseline visit and follow-up assessments as needed up to 2 years
Duration - Up to 2 years
Participants are monitored for up to 2 years to correlate MRI findings with histopathology or clinical follow-up.
Periodic follow-up visits as determined by clinical need
Trial Site Locations
Total: 1 location
1
University Hospitals UZ Leuven, Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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