Clinical Impact of Dedicated MR Staging of Ovarian Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03399344

Acronym

MRStagingOC

Enrollment

270

Registered

2018-01-16

Start date

2018-04-13

Completion date

2022-07-01

Last updated

2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief 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. 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.

Interventions

OTHERMRI

In addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Patients with contraindications for MRI * Patients with contraindications for CRS * Known additional malignancy

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery	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.

Countries

Netherlands

Contacts

Primary ContactMax Lahaye, MD, PhD

m.lahaye@nki.nl0031 20 5129111

Backup ContactMaurits Engbersen

m.engbersen@nki.nl0031 20 5129111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026