Undetermined Ovarian Mass Clinical Trial
— IOTAMRIOfficial title:
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
| Verified date | August 2013 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Observational |
The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.
| Status | Recruiting |
| Enrollment | 74 |
| Est. completion date | December 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: *Any woman with an adnexal mass undetermined by gynecological ultrasound Exclusion Criteria: - Any lesion with definite diagnosis by gynecological ultrasound - Denial or withdrawal of oral informed consent. - Contra-indication for MRI |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospitals UZ Leuven, Gasthuisberg | Leuven | Vlaams-Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation of MRI findings with histopathology or 2-years follow-up | 03/2015 to 03/2017 (up to 2 years) | No |