Ovarian CancerMRStagingOCNCT03399344
Clinical Impact of Dedicated MR Staging of Ovarian Cancer
A study testing MRI in people with Ovarian Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Apr 2018to 1 Jul 2022
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
- Age >18 years
- Written and signed informed consent
- WHO 0-2
- Able to read and write Dutch
Who cannot join
- Patients with contraindications for MRI
- Patients with contraindications for CRS
- Known additional malignancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
NKI-AVL
Amsterdam, 1066CX
Max Lahaye, MD, PhD
About this study
The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.
- Conditions
- Ovarian Cancer
- Being tested
- MRI
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
In addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery.
| Study group | Role | What they receive |
|---|---|---|
| DW-MRI | Other | Patients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
Patients will undergo an additional MRI, besides their regular diagnostic workup, for assessing the extent of peritoneal carcinomatosis. Whether or not complete cytoreductive surgery is feasible will be determined on DW-MRI independently by two radiologists. The outcome wil be defined as the number of cytoreductive procedures correctly predicted by DW-DWI.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start13 Apr 2018
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will undergo an additional MRI, including a diffusion-weighted sequence, for assessing the extent of peritoneal carcinomatosis. Whether or not cytoreductive surgery is feasible will be scored using the peritoneal cancer index on diffusion-weighted magnetic resonance imaging
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399344
- Sponsor's protocol ID
- M17MRO
- Acronym
- MRStagingOC
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berardi E, J van Driel W, H M Hermans R, N Gaarenstroom K, A R Lok C, Persijn-van Meerten ELV, Nederend J, Lambrechts S, Lopez-Yurda M, P Engbersen M, J V Rijsemus C, M J Lambregts D, Laghi A, G J Aalbers A, G H Beets-Tan R, F M Kok N, J Lahaye M. MRI in advanced ovarian cancer: multicentre MISSION trial. Eur J Cancer. 2026 May 2;238:116614. doi: 10.1016/j.ejca.2026.116614. Epub 2026 Feb 26.
PubMed 41780181
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Dedicated MR Staging of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03399344
- Acronym / sponsor ID
- MRStagingOC / M17MRO
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 16 Jan 2018 (actual)
- 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 only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will undergo an additional MRI, including a diffusion-weighted sequence, for assessing the extent of peritoneal carcinomatosis. Whether or not cytoreductive surgery is feasible will be scored using the peritoneal cancer index on diffusion-weighted magnetic resonance imaging
| Arm | Type | Receives |
|---|---|---|
| DW-MRI | Other | Other: MRIPatients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
- Age >18 years
- Written and signed informed consent
- WHO 0-2
- Able to read and write Dutch
Key exclusion criteria (3 listed)
- Patients with contraindications for MRI
- Patients with contraindications for CRS
- Known additional malignancy
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 |
|---|---|---|
| MRIIn addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery. | Other | DW-MRI |
Primary outcome
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
Time frame: 1 month
Patients will undergo an additional MRI, besides their regular diagnostic workup, for assessing the extent of peritoneal carcinomatosis. Whether or not complete cytoreductive surgery is feasible will be determined on DW-MRI independently by two radiologists. The outcome wil be defined as the number of cytoreductive procedures correctly predicted by DW-DWI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 41780181Berardi E, J van Driel W, H M Hermans R, N Gaarenstroom K, A R Lok C, Persijn-van Meerten ELV, Nederend J, Lambrechts S, Lopez-Yurda M, P Engbersen M, J V Rijsemus C, M J Lambregts D, Laghi A, G J Aalbers A, G H Beets-Tan R, F M Kok N, J Lahaye M. MRI in advanced ovarian cancer: multicentre MISSION trial. Eur J Cancer. 2026 May 2;238:116614. doi: 10.1016/j.ejca.2026.116614. Epub 2026 Feb 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Ovarian Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 5 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 22 May 2018. 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 Netherlands. 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?
Contact Max Lahaye, MD, PhD (0031 20 5129111, m.lahaye@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399344, which also lists 1 linked publication.
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 22 May 2018.