Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2025-12-25 @ 5:04 AM
NCT ID: NCT02027818
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.
Study: NCT02027818
Study Brief:
Protocol Section: NCT02027818