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Recruiting

NCT Number: NCT02425540

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

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.

Recruiting

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals UZ Leuven, Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Katrijn Michielsen, Msc

CONTACT

[email protected]

+3216349076

Vincent Vandecaveye, MD, PhD

CONTACT

[email protected]

+3216340518

Vincent Vandecaveye, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic MRI

Device

Primary outcomes

  1. Correlation of MRI findings with histopathology or 2-years follow-up

    Time frame: 03/2015 to 03/2017 (up to 2 years)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: IOTAMRI

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2015
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.