Clinical trial NCT02243059: Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
Official title: Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ovarian Neoplasms
Keywords: Magnetic Resonance Imaging
Gadofosveset trisodium
Nodal imaging
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of MRI in depicting lymph nodes.
timeFrame: One year
Secondary outcomes:
measure: Diagnostic accuracy of MRI.
timeFrame: One year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: University Hospital Maastricht / GROW
name: Toon Van Gorp, Dr
role: PRINCIPAL_INVESTIGATOR
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