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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Recruitment Status : Withdrawn (Problems with availability of study medicine in clinical center)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
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 17, 2014
Last Update Posted Date September 28, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer
Official Title  ICMJE Contrast Enhanced Diffusion-weighted Magnetic Resonance Imaging for Detection of Pathologic Lymph Nodes in Ovarian Cancer - a Feasibility Study.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ovarian Neoplasms
Intervention  ICMJE
  • Drug: Gadofosveset trisodium (Ablavar™ )
    Other Names:
    • Ablavar
    • MS-325
  • Device: MRI
Study Arms  ICMJE Experimental: GDF-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).

Interventions:
  • Drug: Gadofosveset trisodium (Ablavar™ )
  • Device: MRI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 24, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2014)
20
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02243059
Other Study ID Numbers  ICMJE 142030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toon Van Gorp, Dr University Hospital Maastricht / GROW
PRS Account Maastricht University Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP