Undetermined Ovarian MassIOTAMRINCT02425540
Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
An observational study of Undetermined Ovarian Mass, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Undetermined Ovarian Mass
- What is being tested?
- Pelvic MRI
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ovarian mass not able to classify by gynecological ultrasound
Who may be able to join
- Any woman with an adnexal mass undetermined by gynecological ultrasound
Who cannot join
- Any lesion with definite diagnosis by gynecological ultrasound
- Denial or withdrawal of oral informed consent.
- Contra-indication for MRI
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals UZ Leuven, Gasthuisberg
Leuven, Vlaams-Brabant, 3000
Vincent Vandecaveye, MD, PhD, +3216340518, vincent.vandecaveye@uzleuven.be
Katrijn Michielsen, Msc, +3216349076, katrijn.michielsen@uzleuven.be
About this study
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.
- Conditions
- Undetermined Ovarian Mass
- Being tested
- Pelvic MRI
- Keywords
- Pelvic MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| patients with unclassified ovarian mass | Not described Receives: Device: Pelvic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of MRI findings with histopathology or 2-years follow-up
Measured: 03/2015 to 03/2017 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undetermined Ovarian MassStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425540
- Sponsor's protocol ID
- S55783
- Acronym
- IOTAMRI
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2013
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
- ClinicalTrials.gov ID
- NCT02425540
- Acronym / sponsor ID
- IOTAMRI / S55783
- Conditions
- Undetermined Ovarian Mass
- Keywords
- Pelvic MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with unclassified ovarian mass | – | Device: Pelvic MRI |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ovarian mass not able to classify by gynecological ultrasound
Key inclusion criteria (1 listed)
- Any woman with an adnexal mass undetermined by gynecological ultrasound
Key exclusion criteria (3 listed)
- Any lesion with definite diagnosis by gynecological ultrasound
- Denial or withdrawal of oral informed consent.
- Contra-indication for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic MRI | Device | patients with unclassified ovarian mass |
Primary outcome
Correlation of MRI findings with histopathology or 2-years follow-up
Time frame: 03/2015 to 03/2017 (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University Hospitals UZ Leuven, Gasthuisberg
Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undetermined Ovarian Mass, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of MRI findings with histopathology or 2-years follow-up (time frame: 03/2015 to 03/2017 (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.