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

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ClinicalTrials.gov Identifier: NCT03399344
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Impact of Dedicated MR Staging of Ovarian Cancer
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
DW-MRI
Patients with undergo an additional diffusion-weighted MRI in addition to the standard diagnostic work-up
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.




Primary Outcome Measures :
  1. Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females with ovarian cancer
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399344


Contacts
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Contact: Max Lahaye, MD, PhD 0031 20 5129111 m.lahaye@nki.nl
Contact: Maurits Engbersen 0031 20 5129111 m.engbersen@nki.nl

Locations
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Netherlands
NKI-AVL Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Max Lahaye, MD, PhD         
Sponsors and Collaborators
The Netherlands Cancer Institute

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03399344     History of Changes
Other Study ID Numbers: M17MRO
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma