Status:
WITHDRAWN
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 depi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02243059
Start Date
September 1 2014
End Date
September 1 2014
Last Update
September 28 2015
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands, 6229 HX