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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT02243059 |
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Date of registration:
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16/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
MILO |
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Scientific title:
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Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study. |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02243059 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Toon Van Gorp, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Maastricht / GROW |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Neoplasms
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Intervention(s)
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Device: MRI
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Drug: Gadofosveset trisodium (Ablavar™ )
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Primary Outcome(s)
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Feasibility of MRI in depicting lymph nodes.
[Time Frame: One year]
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Secondary Outcome(s)
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Diagnostic accuracy of MRI.
[Time Frame: One year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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