ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

Phase 1

Completed

• Conditions: Breast Cancer.
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT01993576
• Lead Sponsor: Jules Bordet Institute

Brief Summary

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

Detailed Description

Primary objective:

Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).

Secondary objectives:

Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.

Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Status Verified: 2014-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
• Informed Consent signed.

Exclusion Criteria

• Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
• Operation after neo-adjuvant chemotherapy,
• Age less than 18 years.
• For pre-menopausal women, an operation planned for the second phase of their cycle.
• Inability to give informed consent.
• History of allergy or hypersensitivity to the investigational product, iodine.
• Clinical or biological hyperthyroidism.
• Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
• A reported pathological coronary artery disease.
• Creatinine > 1.5 mg / dl.
• During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).
• Pregnancy or breast feeding period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
indocyanine green	Indocyanine Green	Indocyanine green is injected intravenously.

Primary Outcome Measures

Name	Time	Method
Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.	10 months	Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.

Secondary Outcome Measures

Name	Time	Method
Microscopical detection of indocyanine green in breast tissue.	10 months.	Detecting the fluorescence in between benign and malignant tissue by a microscope with a filter for near ifra-red at a good wave length of ICG.

Trial Locations

Locations (1)

Jules Bordet Insitute; 🇧🇪 Brussels, Belgium