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

Breast Cancer. Clinical Trial

— EC2075  

Official title:

Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993576
• Other study ID #: 2013-000100-41
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 6, 2013
• Last updated: October 14, 2014
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2014
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer.

Intervention

Drug:
• Indocyanine Green
Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery

Locations

Country	Name	City	State
Belgium	Jules Bordet Insitute	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.	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.	10 months	No
Secondary	Microscopical detection of indocyanine green in breast tissue.	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.	10 months.	No