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Trial record 1 of 2 for:    "milo" "ovarian"
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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Recruitment Status : Withdrawn (Problems with availability of study medicine in clinical center)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

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).

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: Gadofosveset trisodium (Ablavar™ ) Device: MRI Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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).

Drug: Gadofosveset trisodium (Ablavar™ )
Other Names:
  • Ablavar
  • MS-325

Device: MRI



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Toon Van Gorp, Dr University Hospital Maastricht / GROW
Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02243059    
Other Study ID Numbers: 142030
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2014
Keywords provided by Maastricht University Medical Center:
Magnetic Resonance Imaging
Gadofosveset trisodium
Nodal imaging
Additional relevant MeSH terms:
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Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders