Clinical trial NCT01993576: ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.
Official title: Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer.
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility 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.

Primary outcomes:
measure: Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
timeFrame: 10 months
Secondary outcomes:
measure: Microscopical detection of indocyanine green in breast tissue.
timeFrame: 10 months.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Insitute
Study officials:
affiliation: Jules Bordet Institute
name: Jean-Marie Nogaret, Prof.
role: STUDY_CHAIR
affiliation: Jules Bordet Institute
name: Isabelle Veys, MD
role: STUDY_CHAIR
affiliation: Jules Bordet Institute
name: Sophie VanKerckhove, biologist
role: STUDY_CHAIR
affiliation: Jules Bordet Institute
name: Philippe De Neubourg, MD
role: STUDY_CHAIR
affiliation: Jules Bordet Institute
name: Danielle Noterman, MD
role: STUDY_CHAIR
References: