Evaluation of Two Techniques for the SLN Detection in BC Patients

NCT02032498 | Unknown Phase 2

• 1 other identifier: 2013-001555-12
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

sentinel lymph nodes; radiocolloids; Indocyanine Green; complementarity; axillary lymph node dissection

Outcome Measures

Primary Outcomes (1)

• false negative rate for each technique (fluorescence and radiocolloids)

  1 week

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

superficial injections of Indocyanine Green in the breast

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Superficial injection of ICG in combination with deep injection of 99mTc-HSA to evaluate the complementarity of the two techniques

Also known as: ICG

Indocyanine Green

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Marie Nogaret, MD

  Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Marie Nogaret, MD

CONTACT

00322541; jeanmarie.nogaret@bordet.be

Pierre Bourgeois, MD

CONTACT

00322541; pierre.bourgeois@bordet.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: January 10, 2014
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

BE (1)