Clinical Impact of Dedicated MR Staging of Ovarian Cancer

NCT03399344 | Unknown

• 1 other identifier: M17MRO
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DW-MRI

OTHER

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

Other: MRI

Interventions

MRI OTHER

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

DW-MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: females with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

NKI-AVL

Amsterdam, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Max Lahaye, MD, PhD

CONTACT

0031 20 5129111; m.lahaye@nki.nl

Maurits Engbersen

CONTACT

0031 20 5129111; m.engbersen@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: April 13, 2018
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 22, 2018

Record last verified: 2018-01

Locations

NL (1)