- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993576
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue. (EC2075)
Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
Study Overview
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Brussels, Belgium, B-1000
- Jules Bordet Insitute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
Other Names:
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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
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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.
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10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microscopical detection of indocyanine green in breast tissue.
Time Frame: 10 months.
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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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10 months.
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Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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