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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Indocyanine Green||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
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
|Jules Bordet Institute||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Pierre Bourgeois, MD 003225413276 firstname.lastname@example.org|
|Principal Investigator: Isabelle Veys, MD|
|Principal Investigator:||Isabelle Veys, MD||Surgeon in Jules Bordet Institute|