Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
- Conditions
- Ovarian Neoplasms
- Interventions
- Device: MRI
- Registration Number
- NCT02243059
- Lead Sponsor
- Maastricht University Medical Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
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Patients estimated to have more benefit from neoadjuvant chemotherapy
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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).
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Previous para-aortic or pelvic lymphadenectomy
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History of a malignant tumour.
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Pregnant or lactating patients. Incapacitated subjects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GDF-MRI Gadofosveset trisodium (Ablavar™ ) In this pilot study, all included patients will undergo conventional MRI with contrast enhancement (gadofosveset trisodium) and diffusion weighted MRI. Ablavar™ solution contains 244 mg/mL (0.25 mmol/mL) gadofosveset trisodium. 0.03 mmol/kg of gadofosveset will be administered by manual injection as a single intravenous bolus injection over a period of time up to 30 seconds followed by a 25-30 ml saline flush. In practice, this comes down to the maximum of one vial for one patient (one vial contains 10 ml solution, which contains a total of 2.50 mmol of gadofosveset trisodium equivalent to 2.27 g of gadofosveset). GDF-MRI MRI In this pilot study, all included patients will undergo conventional MRI with contrast enhancement (gadofosveset trisodium) and diffusion weighted MRI. Ablavar™ solution contains 244 mg/mL (0.25 mmol/mL) gadofosveset trisodium. 0.03 mmol/kg of gadofosveset will be administered by manual injection as a single intravenous bolus injection over a period of time up to 30 seconds followed by a 25-30 ml saline flush. In practice, this comes down to the maximum of one vial for one patient (one vial contains 10 ml solution, which contains a total of 2.50 mmol of gadofosveset trisodium equivalent to 2.27 g of gadofosveset).
- Primary Outcome Measures
Name Time Method Feasibility of MRI in depicting lymph nodes. One year 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.
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy of MRI. One year 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.
Trial Locations
- Locations (1)
University Hospital Maastricht
🇳🇱Maastricht, Netherlands