Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging (IOTAMRI)

July 12, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • University Hospitals UZ Leuven, Gasthuisberg
        • Principal Investigator:
          • Vincent Vandecaveye, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with ovarian mass not able to classify by gynecological ultrasound

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with unclassified ovarian mass
Device: Pelvic MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of MRI findings with histopathology or 2-years follow-up
Time Frame: 03/2015 to 03/2017 (up to 2 years)
03/2015 to 03/2017 (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimated)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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