NCT03619967

Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: Female
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images. To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.

Detailed description

Per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. Initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. While the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera. All resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. Results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Multispectral imager	Device: Bio-inspired multispectral imager -Manufactured at University of Illinois at Urbana Champaign

Timeline

• Start date: 2018-07-20
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2018-08-08
• Last updated: 2022-05-25

Locations

1 site across 1 country: North Macedonia