Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer (MILO)
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|ClinicalTrials.gov Identifier: NCT02243059|
Recruitment Status : Withdrawn (Problems with availability of study medicine in clinical center)
First Posted : September 17, 2014
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: Gadofosveset trisodium (Ablavar™ ) Device: MRI||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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).
Drug: Gadofosveset trisodium (Ablavar™ )
- Feasibility of MRI in depicting lymph nodes. [ Time Frame: 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.
- Diagnostic accuracy of MRI. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243059
|University Hospital Maastricht|
|Maastricht, Netherlands, 6229 HX|
|Principal Investigator:||Toon Van Gorp, Dr||University Hospital Maastricht / GROW|