Gadofosveset for Axillary Staging in Breast Cancer Patients

NCT ID: NCT01437865

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadofosveset enhanced MRI Axilla

Group Type: EXPERIMENTAL

Gadofosveset contrast agent enhanced MRI Axilla

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R. Beets - Tan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center (MUMC) AZM

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

11-2-016

Identifier Type: -

Identifier Source: org_study_id