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Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study


N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study


Inclusion Criteria:



1. Patient with histopathologically confirmed invasive breast cancer about to undergo
nodal staging.

2. Tumor must be a T2 according the TNM 6-classification.

3. The ultrasound of the axilla must be suspect for nodal metastases.

4. Willing and able to undergo all study procedures

5. Has personally provided written informed consent.

Exclusion Criteria:

1. Age <18

2. History of prior chemotherapy

3. History of prior radiotherapy of the surrounding areas of the axilla.

4. Pregnancy

5. Contra indications for MRI such as pacemaker, aneurysm clips or severe
claustrophobia.

6. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)

7. Being unable to give informed consent in person

8. Acute or chronic severe renal insufficiency (glomerular filtration rate <30
mL/min/1.73m2).

9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the
perioperative liver transplantation period.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases

Outcome Description:

The main study parameter will be the accuracy (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 accuray 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. 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:

11-2-016

NCT ID:

NCT01437865

Start Date:

September 2011

Completion Date:

March 2012

Related Keywords:

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

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