Gadofosveset for Axillary Staging in Breast Cancer Patients
This study has been completed.
Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01437865
First received: September 12, 2011
Last updated: April 5, 2012
Last verified: April 2012
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Purpose
The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods.
The accuracy 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 SNLB or ALND will be regarded as the golden standard for nodal involvement.
| Condition | Intervention |
|---|---|
|
Breast Neoplasms |
Drug: Gadofosveset contrast agent enhanced MRI Axilla |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Gadofosveset trisodium
U.S. FDA Resources
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- The accuracy (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. ] [ Designated as safety issue: No ]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.
| Enrollment: | 10 |
| Study Start Date: | September 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gadofosveset enhanced MRI Axilla |
Drug: Gadofosveset contrast agent enhanced MRI Axilla
A MRI 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 Name: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
- Tumor must be a T2 according the TNM 6-classification.
- The ultrasound of the axilla must be suspect for nodal metastases.
- Willing and able to undergo all study procedures
- Has personally provided written informed consent.
Exclusion Criteria:
- Age <18
- History of prior chemotherapy
- History of prior radiotherapy of the surrounding areas of the axilla.
- Pregnancy
- Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
- Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
- Being unable to give informed consent in person
- Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2).
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437865
Locations
| Netherlands | |
| Maastricht University Medical Center (MUMC) AZM | |
| Maastricht, Netherlands | |
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
| Principal Investigator: | R. Beets - Tan, MD, PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01437865 History of Changes |
| Other Study ID Numbers: | 11-2-016 |
| Study First Received: | September 12, 2011 |
| Last Updated: | April 5, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
MRI lymph node metastases breast cancer gadofosveset |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013