Gadofosveset for Axillary Staging in Breast Cancer Patients

NCT01437865 | Completed

• 1 other identifier: 11-2-016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

MRI; lymph node metastases; breast cancer; gadofosveset

Outcome Measures

Primary Outcomes (1)

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

  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.

  Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.

Study Arms (1)

Gadofosveset enhanced MRI Axilla

EXPERIMENTAL

Drug: Gadofosveset contrast agent enhanced MRI Axilla

Interventions

Gadofosveset contrast agent enhanced MRI Axilla DRUG

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.

Also known as: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601

Gadofosveset enhanced MRI Axilla

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center (MUMC) AZM

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Interventions

gadofosveset trisodium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• R. Beets - Tan, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

NL (1)