NCT02027818

Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-01-06
• Last updated: 2023-12-15

Locations

1 site across 1 country: Belgium