Clinical trial NCT03619967: Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Official title: Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
sentynel lymph node
fluorescence imaging
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Ss. Cyril and Methodius University of Skopje, Macedonia
First posted: 2018-08-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* early or progressive stage of breast cancer
* able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* inflammatory cancerous tissue
* pregnant women
* history of allergic reactions to iodide or seafood allergy
* sentinel lymph nodes were not detected with radiocolloid and static gamma camera
* patients have previous breast surgery
* patients who were unwilling to enter the study

Primary outcomes:
measure: Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
timeFrame: Up to 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Skopje
country: North Macedonia
facility: University Clinic Hospital
Study officials:
affiliation: UIUC
name: Viktor Gruev, PhD
role: PRINCIPAL_INVESTIGATOR
References: