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

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ClinicalTrials.gov Identifier: NCT02032563
Recruitment Status : Unknown
Verified July 2014 by Jules Bordet Institute.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

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
Breast Cancer 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : December 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: ICG




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 [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02032563


Locations
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Belgium
Jules Bordet Institute Recruiting
Brussels, Belgium, 1000
Contact: Pierre Bourgeois, MD    003225413276    pierre.bourgeois@bordet.be   
Principal Investigator: Isabelle Veys, MD         
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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Principal Investigator: Isabelle Veys, MD Surgeon in Jules Bordet Institute

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT02032563     History of Changes
Other Study ID Numbers: BR-ICG-IV-NACT
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Jules Bordet Institute:
neoadjuvant therapy