Intraoperative Imaging of Lymph Nodes

Trial Title: Intraoperative Imaging of Lymph Nodes

NCT ID: NCT06276439

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
autofluorescence
near infrared fluorescence
Indocyanine Green
ICG

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Procedure
Intervention name: Surgical removal of breast cancer and lymph nodes
Description: The patients will undergo a surgical procedure to remove tumor tissue in the breast and its associated lymph nodes. No clinical decision is based on the imaging device tested.
Arm group label: Positive lymph node detection with bioinspired sensor
Arm group label: Positive lymph node detection with highly sensitive imaging sensor

Summary: One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers.

Detailed description: The objective of this study is to evaluate the sensitivity of our two new imaging technologies (bioinspired imaging sensor and low noise imaging sensor) to detect positive sentinel lymph nodes in patients with breast cancer. We will achieve this by recording fluorescence emitted by an FDA-approved fluorescent probe known as Indocyanine Green (ICG) in ex vivo resected samples. ICG is routinely used during cancer surgeries around the world because it passively accumulates in sentinel lymph nodes. Due to the bright green coloration of ICG, surgeons can visually identify the location of the sentinel lymph node, resect them and stage the patient's cancer based on pathology results. Since ICG is also fluorescent in the near infrared spectrum, our imaging sensor can locate the sentinel lymph node quicker and more accurately than when using unaided visual inspection. Once the lymph node is located using near-infrared (NIR) imaging with indocyanine green (ICG), the extracted samples will be placed on a separate table. These samples will be subjected to ultraviolet (UV) light to check for any natural autofluorescence. A strong autofluorescence indicates the sample is likely positive or metastatic, suggesting the presence of cancer cells. Subsequent histopathological analysis will further examine these samples. The findings will be used to construct a receiver operating curve, which will help in determining the accuracy of detecting cancer-positive lymph nodes using both exogenous (ICG-induced) and endogenous (natural) fluorescence with the two imaging systems.

Criteria for eligibility:

Study pop:
The population we are studying has been diagnosed with early or progressive stage of breast cancer who need to be treated with breast surgery. The participants will undergo breast tumor removal per standard practices.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - early or progressive stage of breast cancer who needs to be treated with breast surgery Exclusion Criteria: - pregnant women - previous breast cancer surgery - history of allergic reactions to iodide or seafood allergy. - man

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Clinic Hospital

Address:
City: Skopje
Zip: 1000
Country: North Macedonia

Status: Recruiting

Contact:
Last name: Viktor Gruev, PhD

Phone: +1.267.847.4020
Email: vgruev@illinois.edu

Contact backup:
Last name: Goran Kondov, MD, PHD

Phone: +389 70 252010
Email: kondov@yahoo.com

Start date: February 19, 2024

Completion date: February 19, 2026

Lead sponsor:
Agency: University of Illinois at Urbana-Champaign
Agency class: Other

Collaborator:
Agency: U.S. National Science Foundation
Agency class: U.S. Fed

Collaborator:
Agency: Ss. Cyril and Methodius University of Skopje, Macedonia
Agency class: Other

Source: University of Illinois at Urbana-Champaign

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06276439