Evaluation of Two Techniques for the SLN Detection in BC Patients

Evaluation of Near- InfraRed Imaging of ICG in Comparison With the Lymphoscintigraphic Technique Using Intramammary and Peritumoral Injection of 99mTc-HSA-Nanocolloids for the SLN Detection in BC Patients.

The revision of our data shows that since its introduction in our institution (Jules Bordet Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional axillary dissection.

The analysis of these cases shows that:

• The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is associated in 75% of them with a pN+ status
• If scintigraphic imaging is "positive" (demonstration of the sentinel lymph nodes: 35 cN0 and 10 cN+), our results appear favorable with a single false negative SLN result (False Negative Rate = 1/20 or 5%).

Therefore we propose additional technique for LN detection by indocyanine green, we hypothesize that the combination of two different injections improves the technique of sentinel lymph node biopsy.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Indocyanine Green

Detailed Description

The principal objective of this study is to evaluate the detection rate, the false negative rate and the overall accuracy of the lymphofluoroscopic research of the sentinel lymph nodes after periareolar injections of Indocyanine Green (ICG) in combination and in comparison with our classical intramammary and peritumoral injections of 99mTc-HSA-Nanocolloids in patients with breast cancer. These patients are currently out of the inclusion criteria and still undergo systematically complete axillary node dissection.

In this study (which would include at least 200 patients over a period of 2 years, with at least 100 patients after neoadjuvant chemotherapy) the involved surgeons would continue to perform complete axillary node dissections.

The radioactive SLN would be retrieved ex vivo in the axillary piece (with the gamma probe, after intramammary and peritumoral injections of radiocolloids the day before the surgery, or at least 3 hours before, with scintigraphic preoperative images as already performed routinely for patients described in the introduction 1 of this letter). These radioactive lymph nodes would thereafter been controlled for their possible fluorescence (with our fluorescence camera and after periareolar injection of ICG in the operating room just before the surgery). Finally, in the service of Pathology, all the lymph nodes found by the pathologist in the axillary piece will be controlled for their possible fluorescence.

With this approach, the surgeon will not have to search for SLN and the operative duration will not be extended.

Secondary objectives:

The current literature about the results of SLNB technique has not yet considered the influence of the addition of SPECT-CT imaging (standard approach in our institute since more than 3 years) to planar imaging. In this study, we propose to analyse in a prospective manner the contribution of SPECT-CT: contribution of the analysis of the signal intensity of active lymph nodes on SPECT slides to define a resection threshold corresponding to lymph nodes at risk of being pN+, accuracy for the anatomic localization, better accuracy of the number of SLN on the SPECT-CT versus planar image, better definition of the number of lymph nodes (to be analysed on the CT) covered by a radioactive spot (we have already observed 3 adjacent lymph nodes under one only active spot).

In this last case, such spots covering several lymph nodes would be analysed for the possible fluorescence of each lymph node.

The fluorescence of the detected lymph nodes will be analysed semi-quantitatively and related to their pN+ characteristics (pNi, pNµ, pN1, pNmacro). This first analysis may have major implications when our surgeons will perform an in vivo research of fluorescent SLN (see also Bourgeois et al. 2003).

Finally, we propose to analyse the kinetic and the vascular characteristics (aspects of the vessels on the images) of ICG migration from its injection point to the axilla. We will try to define possible predictive parameters of extended and/or macroscopic involvement of axillary lymph nodes.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jean-Marie Nogaret, MD; Phone Number: 3165 00322541; Email: jeanmarie.nogaret@bordet.be
• Study Contact Backup: Name: Pierre Bourgeois, MD; Phone Number: 3276 00322541; Email: pierre.bourgeois@bordet.be

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Recruiting
    • Jules Bordet Institute
    • Contact: Pierre Bourgeois, MD; Phone Number: 003225413276; Email: pierre.bourgeois@bordet.be
    • Principal Investigator: Jean-Marie Nogaret, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients submitted to mastectomy or tumorectomy with Complete Axillary Node Dissection (but to whose SLN procedure might be proposed in the future).
• General operability.
• Informed consent form signed

Exclusion Criteria:

• Age less than18 years old.
• Former operation in the axilla and/or breast.
• Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall.
• History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
• Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
• Documented coronary disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indocyanine Green; superficial injections of Indocyanine Green in the breast	Drug: Indocyanine Green; Superficial injection of ICG in combination with deep injection of 99mTc-HSA to evaluate the complementarity of the two techniques; Other Names: ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
false negative rate for each technique (fluorescence and radiocolloids)	1 week

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Investigators: Principal Investigator: Jean-Marie Nogaret, MD, Surgeon

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: axillary lymph node dissection; Indocyanine Green; sentinel lymph nodes; radiocolloids; complementarity
• Other Study ID Numbers: 2013-001555-12