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ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue. (EC2075)

Primary Purpose

Breast Cancer.

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Indocyanine Green

About this trial

This is an interventional diagnostic trial for Breast Cancer.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Jules Bordet Insitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

indocyanine green

Arm Description

Indocyanine green is injected intravenously.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01993576

First Posted

May 6, 2013

Last Updated

October 14, 2014

Sponsor

Jules Bordet Institute

1. Study Identification

Unique Protocol Identification Number

NCT01993576

Brief Title

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

Acronym

EC2075

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jules Bordet Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer.

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

indocyanine green

Arm Type

Experimental

Arm Description

Indocyanine green is injected intravenously.

Intervention Type

Drug

Intervention Name(s)

Indocyanine Green

Other Intervention Name(s)

ICG

Intervention Description

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

Primary Outcome Measure Information:

Title

Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.

Description

Time Frame

10 months

Secondary Outcome Measure Information:

Title

Microscopical detection of indocyanine green in breast tissue.

Description

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.

Time Frame

10 months.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: