MedTrace Logo

Gadofosveset for Axillary Staging in Breast Cancer Patients

NCT01437865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-04-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • R. Beets - Tan, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437865 on ClinicalTrials.gov