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Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer

NCT02243059 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-09-28

No results posted yet for this study

Summary

Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging strategies to depict involved lymph nodes are currently not successful. The purpose of this study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian cancer undergoing primary debulking surgery and compare this to conventional imaging with computer tomography (CT).

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Gadofosveset trisodium (Ablavar™ )

DEVICE

MRI

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Toon Van Gorp, Dr · University Hospital Maastricht / GROW

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243059 on ClinicalTrials.gov