Clinical Impact of Dedicated MR Staging of Ovarian Cancer

Ovarian Cancer Clinical Trial

— MRStagingOC  

Official title:

Clinical Impact of Dedicated MR Staging of Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399344
• Other study ID #: M17MRO
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2018
• Source: The Netherlands Cancer Institute
• Contact: Max Lahaye, MD, PhD
• Phone: 0031 20 5129111
• Email: m.lahaye[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month