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Clinical Impact of Dedicated MR Staging of Ovarian Cancer (MRStagingOC)

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MRI
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • NKI-AVLRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DW-MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2018
Last Updated
May 18, 2018
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03399344
Brief Title
Clinical Impact of Dedicated MR Staging of Ovarian Cancer
Acronym
MRStagingOC
Official Title
Clinical Impact of Dedicated MR Staging of Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DW-MRI
Arm Type
Other
Arm Description
Patients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
In addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery.
Primary Outcome Measure Information:
Title
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
Description
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.
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females with ovarian cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Max Lahaye, MD, PhD
Phone
0031 20 5129111
Email
m.lahaye@nki.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Maurits Engbersen
Phone
0031 20 5129111
Email
m.engbersen@nki.nl
Facility Information:
Facility Name
NKI-AVL
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Lahaye, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Clinical Impact of Dedicated MR Staging of Ovarian Cancer

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