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Nodal Staging in Breast Cancer With MRL

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ClinicalTrials.gov Identifier: NCT01609920
Recruitment Status : Terminated (Manufacturer recently halted production of gadofosveset.)
First Posted : June 1, 2012
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).

The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.


Condition or disease Intervention/treatment
Breast Neoplasms Drug: Gadofosveset enhanced MRL of axillary lymph nodes

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
Study Start Date : May 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gadofosveset MRL Drug: Gadofosveset enhanced MRL of axillary lymph nodes
A MRL of the axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.
Other Names:
  • Vasovist
  • Ablavar
  • Gadofosveset



Primary Outcome Measures :
  1. The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases [ Time Frame: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks. ]
    The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the diagnostic performace can be calculated.



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

Inclusion Criteria:

  1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
  2. Willing and able to undergo all study procedures
  3. Has personally provided written informed consent.

Exclusion Criteria:

  1. Age <18,
  2. Pregnancy
  3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
  4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
  5. Being unable to give informed consent in person
  6. Acute or chronic severe renal insufficiency (glomerular filtration rate <45 mL/min/1.73m2)1.
  7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.
  8. Known (or suspicion of) QT- prolongation

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): NCT01609920


Locations
Netherlands
Maastricht University Medical Center (MUMC) AZM
Maastricht, Limburg, Netherlands, 6225 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: R.G.H. Beets-Tan, MD, PhD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01609920     History of Changes
Other Study ID Numbers: 12-2-032
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: May 2013

Keywords provided by Maastricht University Medical Center:
MRI
lymph node metastases
breast cancer
gadofosveset

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases