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Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer

NCT02243059WithdrawnPHASE4INTERVENTIONAL

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).

Key Facts

Lead Sponsor

Maastricht University Medical Center

Enrollment

Start Date

2014-09-01

Completion Date

2014-09-01

Study Type

INTERVENTIONAL

Official Title

Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.

Interventions

Gadofosveset trisodium (Ablavar™ )MRI

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Non-pregnant female
* Expected FIGO stage IIB-IV epithelial ovarian carcinoma
* Scheduled for primary debulking surgery
* Written informed consent
* At least 18 years of age.

Exclusion Criteria:

* Patients estimated to have more benefit from neoadjuvant chemotherapy
* Ineligibility to undergo MRI

  * Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, etcetera).
  * Claustrophobia
* Ineligibility to receive gadofosveset contrast (history of contrast allergy,

  * History of a prior allergic reaction to the active substance or to any of the excipients of Ablavar™.
  * Impaired kidney function (Glomerular Filtration Rate \<30 ml/min/1.73m2).
* Previous para-aortic or pelvic lymphadenectomy
* History of a malignant tumour.
* Pregnant or lactating patients. Incapacitated subjects

Outcome Measures

Primary Outcomes

Feasibility of MRI in depicting lymph nodes.

Primary outcome measure is to determine the optimal imaging settings and feasibility of MRI combined with DW-MRI and GDF-MRI (gadofosveset-MRI) in the identification of pathologic lymph nodes in women with advanced stage epithelial ovarian cancer.

Time frame: One year

Secondary Outcomes

Diagnostic accuracy of MRI.

Sensitivity, specificity, positive predictive value and negative predictive value for the detection of metastatic lymph nodes will be calculated for MRI (+/- DW-MRI and GDF-MRI) and compared with conventional CT imaging.

Time frame: One year

Locations

University Hospital Maastricht, Maastricht, Netherlands

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.