Clinical Impact of Dedicated MR Staging of Ovarian Cancer

NCT ID: NCT03399344

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DW-MRI

Patients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up

Group Type OTHER

MRI

Intervention Type OTHER

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

Interventions

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MRI

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NKI-AVL

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Max Lahaye, MD, PhD

Role: CONTACT

0031 20 5129111

Maurits Engbersen

Role: CONTACT

0031 20 5129111

Facility Contacts

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Max Lahaye, MD, PhD

Role: primary

Other Identifiers

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M17MRO

Identifier Type: -

Identifier Source: org_study_id

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