Skip to main content
OpenTrials
Completed

NCT Number: NCT01993576

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer. Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jules Bordet Insitute

Brussels, Belgium, B-1000

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine green

Drug

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

Other names: ICG

Primary outcomes

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

    Time frame: 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 outcomes

  1. Microscopical detection of indocyanine green in breast tissue.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

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

Acronym: EC2075

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.