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Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy

Sponsor
Jules Bordet Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02032563
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
10
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine Green
 Phase 2

Detailed 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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of the (Intravenously Injected) Indocyanine Green Distribution in Tumour Bearing Breasts and in Axillary Pieces of Dissection of Patients Who Have Received Neoadjuvant Therapy for Histologically Proven Mammary Cancer
Study Start Date :
Dec 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2014
Anticipated Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Indocyanine Green

intravenous injection of 0.25mg/kg Indocyanine Green just before surgery

Drug: Indocyanine Green
intravenous injection of 0.25mg/kg Indocyanine Green just before the surgery
Other Names:
  • ICG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. fluorescence intensity of tumoral lesions, scars and healthy tissues after IV injection of ICG in breast cancer patients after neoadjuvant therapy [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,

    • Age less than18 years old.

    • Inability to give informed consent.

    • History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.

    • Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.

    • Documented coronary disease.

    • Advanced renal impairment (creatinine > 1,5mg/dl).

    • During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).

    • Pregnancy, breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jules Bordet Institute Brussels Belgium 1000

    Sponsors and Collaborators

    • Jules Bordet Institute

    Investigators

    • Principal Investigator: Isabelle Veys, MD, Surgeon in Jules Bordet Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jules Bordet Institute
    ClinicalTrials.gov Identifier:
    NCT02032563
    Other Study ID Numbers:
    • BR-ICG-IV-NACT
    First Posted:
    Jan 10, 2014
    Last Update Posted:
    Jul 24, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Jules Bordet Institute
    neoadjuvant therapy

    Study Results

    No Results Posted as of Jul 24, 2014