We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nodal Staging in Breast Cancer With MRL

This study has been terminated.
(Manufacturer recently halted production of gadofosveset.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609920
First Posted: June 1, 2012
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
May 30, 2012
June 1, 2012
November 10, 2016
May 2012
May 2016   (Final data collection date for primary outcome measure)
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.
The diagnostic performance (sensitivity, specificity, NPV and PPV) of the MRI 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 MRI in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRI 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.
Complete list of historical versions of study NCT01609920 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nodal Staging in Breast Cancer With MRL
Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Breast Neoplasms
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
Experimental: Gadofosveset MRL
Intervention: Drug: Gadofosveset enhanced MRL of axillary lymph nodes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
97
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01609920
12-2-032
No
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: R.G.H. Beets-Tan, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
May 2013

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