Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-11 @ 12:50 PM
Study NCT ID:
NCT02027818
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy
Sponsor:
Jules Bordet Institute
Organization:
Study Overview
Official Title:
Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent
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.
The surgeon will remove the tumour (and the axillary lymph nodes) as usual.
Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.
In the Laboratory of Pathology:
The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).
After fixation, the tumoral tissues will be thereafter processed "as usual".
If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.
Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.
ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
The surgeon will remove the tumour (and the axillary lymph nodes) as usual.
Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.
In the Laboratory of Pathology:
The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).
After fixation, the tumoral tissues will be thereafter processed "as usual".
If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.
Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: