Axillary Reverse Mapping for Breast Carcinomas (SENTIBRAS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01146158

First received: April 23, 2010

Last updated: June 16, 2010

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2010

Last Updated Date

June 16, 2010

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Success of the principal objectives is qualified as finding one or more radioactive node in zone D [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein.

If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01146158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Evaluate the incidence of metastatic or micro-metastatic disease within
Evaluate the correlation between clinical and histological results [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Evaluate the correlation between clinical and histological results
Evaluate the morbidity associated with Axillary Dissection. [ Time Frame: 1 year, 2 years and 5 years ] [ Designated as safety issue: No ]
Evaluate the morbidity associated with Axillary Dissection.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Axillary Reverse Mapping for Breast Carcinomas

Official Title ^ICMJE

Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

Brief Summary

Detailed Description

Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Axillary Dissection

Intervention ^ICMJE

Procedure: Axillary dissection for breast carcinomas

surgery Axillary dissection

Other Name: surgery Axillary dissection

Study Arm (s)

Experimental: surgery Axillary dissection

surgery Axillary dissection

Intervention: Procedure: Axillary dissection for breast carcinomas

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Indication for formal Axillary Dissection (AD)
N0 patient with a large tumor: T3
N1 patient
N2 patient with axillary imaging showing limited node involvement(1-4N+).
Secondary AD after a positive sentinel node ( pN1, pN1(mi))
AD after préopérative chemotherapy in a patient initially N+.
Age between 18 and 70
Signature of the consent form.
Patients beneficiary of the Social Security

Exclusion Criteria:

N0 patient with an indication of Sentinel Node biopsy
N2 patient with axillary imaging showing suspected node involvement >4N+.
N3 patient
Age over 70
Pregnancy
Blue dye allergy
Mentally deficient patient

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Claude NOS, MD

00 (33) 6 26 27 53 58

claude.nos@egp.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01146158

Other Study ID Numbers ^ICMJE

P070154

Has Data Monitoring Committee

Yes

Responsible Party

Brindel Isabelle, Department of Clinical Research and Development

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claude NOS, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top