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

October 14, 2014 updated by: Jules Bordet Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1000
        • Jules Bordet Insitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: indocyanine green
Indocyanine green is injected intravenously.
Drug: Indocyanine Green
Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Study Chair: Jean-Marie Nogaret, Prof., Jules Bordet Institute
  • Study Chair: Isabelle Veys, MD, Jules Bordet Institute
  • Study Chair: Sophie VanKerckhove, biologist, Jules Bordet Institute
  • Study Chair: Philippe De Neubourg, MD, Jules Bordet Institute
  • Study Chair: Danielle Noterman, MD, Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-000100-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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