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Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset


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 (VasovistĀ® /AblavarĀ®)

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

R.G.H. Beets-Tan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

12-2-032

NCT ID:

NCT01609920

Start Date:

May 2012

Completion Date:

March 2014

Related Keywords:

  • Breast Neoplasms
  • MRI
  • lymph node metastases
  • breast cancer
  • gadofosveset
  • Breast Neoplasms
  • Neoplasms

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