Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- Informed consent form signed.
- Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
- Informed consent form signed.
- Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
Exclusion Criteria
- Inability to give informed consent.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Pregnancy, breastfeeding
- ...
- Inability to give informed consent.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Pregnancy, breastfeeding
- Documented coronary disease.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- Advanced renal impairment (creatinine > 1,5mg/dl).
- Age less than18 years old.
- Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,
Summary
- Conditions
- Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only females
Description
In the operating room: ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation. Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluores...
In the operating room: ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation. Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity). Optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. The tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the PDE camera (in comparison with standards of known fluorescence intensity). In the Laboratory of Pathology: The fresh mammary piece will be processed as usual, but the "gross-thick" sections will be imaged using the PDE and the fluorescent areas will be defined (and later analyzed in comparison with standards of known fluorescence intensity). After fixation, the tumoral tissues as well as - if identified - non tumoral fluorescent foci will be thereafter processed "as usual". All the slides obtained will be analyzed using the NIR fluorescent microscope for the presence or not of detectable ICG and the ICG-positive tissues or compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages…) will be determined. If fluorescent foci are identified at the level of the axillary piece, they will be isolated and analyzed like the other lymph nodes. Using the NIR fluorescent microscope, these isolated macroscopically fluorescent structures will be analyzed (lymph node? Other?). Additionally, metastatic lymph nodes will also be controlled for their microscopic fluorescence or not.
Inclusion Criteria
- Informed consent form signed.
- Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
- Informed consent form signed.
- Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
Exclusion Criteria
- Inability to give informed consent.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Pregnancy, breastfeeding
- ...
- Inability to give informed consent.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Pregnancy, breastfeeding
- Documented coronary disease.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- Advanced renal impairment (creatinine > 1,5mg/dl).
- Age less than18 years old.
- Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,
Tracking Information
- NCT #
- NCT02032563
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Isabelle Veys, MD Surgeon in Jules Bordet Institute
- Isabelle Veys, MD Surgeon in Jules Bordet Institute