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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Breast Cancer.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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indocyanine green

Indocyanine green is injected intravenously.

Group Type EXPERIMENTAL

Indocyanine Green

Intervention Type DRUG

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

Interventions

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Indocyanine Green

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

Intervention Type DRUG

Other Intervention Names

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ICG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No