Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Multispectral imager
Intervention type(s): Device
Intervention description(s): Device: Bio-inspired multispectral imager
-Manufactured at University of Illinois at Urbana Champaign
Intervention model: Single Group Assignment
Intervention model description: Experimental: Arm 1: Multispectral Imaging Per current standard of care for patients with breast cancer, three different tracers will be injected in the patient: technetium radiocolloid, indocyanine green and methylene blue. 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. During this same time period, fluorescent signals from the underarm surgical wound site will be recorded with the bio-inspired multispectral camera.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: breast cancer; sentynel lymph node; fluorescence imaging