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

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ClinicalTrials.gov Identifier: NCT01993576
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer. Drug: Indocyanine Green Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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 Name: ICG




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993576


Locations
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Belgium
Jules Bordet Insitute
Brussels, Belgium, B-1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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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
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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01993576    
Other Study ID Numbers: 2013-000100-41
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases