Nodal Staging in Breast Cancer With MRL

NCT01609920 | Terminated

• 1 other identifier: 12-2-032
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance 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 sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (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 diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases

  The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL 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 diagnostic performace 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 MRL

EXPERIMENTAL

Drug: Gadofosveset enhanced MRL of axillary lymph nodes

Interventions

Gadofosveset enhanced MRL of axillary lymph nodes DRUG

A MRL 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: Vasovist, Ablavar, Gadofosveset

Gadofosveset MRL

Eligibility Criteria

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

You may qualify if:

• Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
• Willing and able to undergo all study procedures
• Has personally provided written informed consent.

You may not qualify if:

• Age \<18,
• Pregnancy
• Contra indications for MRL 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 \<45 mL/min/1.73m2)1.
• Acute renal insufficiency of any severity due to the hepato-renal syndrome.
• Known (or suspicion of) QT- prolongation

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center (MUMC) AZM

Maastricht, Limburg, 6225 HX, 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.G.H. 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: May 30, 2012
• First Posted: June 1, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2013-05

Locations

NL (1)