NCT02425540

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

9.9 years

First QC Date

August 14, 2013

Last Update Submit

July 12, 2024

Conditions

Undetermined Ovarian Mass

Keywords

Pelvic MRI

Outcome Measures

Primary Outcomes (1)

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

    03/2015 to 03/2017 (up to 2 years)

Study Arms (1)

patients with unclassified ovarian mass

Device: Pelvic MRI

Interventions

Pelvic MRIDEVICE
patients with unclassified ovarian mass

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ovarian mass not able to classify by gynecological ultrasound

You may qualify if:

  • \*Any woman with an adnexal mass undetermined by gynecological ultrasound

You may not qualify if:

  • Any lesion with definite diagnosis by gynecological ultrasound
  • Denial or withdrawal of oral informed consent.
  • Contra-indication for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals UZ Leuven, Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2013

First Posted

April 24, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2025

Study Completion

December 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

BE(1)