Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - ICG enhanced SLNB

• Conditions: Women above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedure; MedDRA version: 9.1Level: LLTClassification code 10006194Term: Breast cancer NOS stage I; MedDRA version: 9.1Level: LLTClassification code 10006195Term: Breast cancer NOS stage II

• Registration Number: EUCTR2009-011079-57-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women above 21 years of age with stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology and who have given informed consent according to the rules of the hospital. Patient is undergoing sentinel lymph node mapping for staging and treatment of their disease.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Refusal of the patient to be included in the study.
2. Pregnant or breast-feeding.
3. History of iodine allergy or anaphylactic reactions to insect bites or medication.
4. Presence or history of hyperthyroidism.
5. Recent surgery on the armpit.
6. Significant renal (serum creatinine = 400 µmol/L) dysfunction.
7. Cardiac and/or pulmonary disease (ASA III-IV).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and patent blue) in detecting sentinel lymph nodes in breast surgery. ;Secondary Objective: The number of lymph nodes detected by ICG enhanced NIRF imaging during breast surgery. ;Primary end point(s): Whether ICG enhanced NIRF imaging is able to detect sentinel lymph nodes as good as or better than the standard technique (technetium-99 labeled colloid and patent blue) during breast surgery in 97%± 2% of the cases.