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Intraoperative Imaging of Lymph Nodes

Intraoperative Imaging of Indocyanine Green for Sentinel Lymph Node Mapping

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06276439
Enrollment
48
Registered
2024-02-26
Start date
2024-02-19
Completion date
2026-02-19
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, autofluorescence, near infrared fluorescence, Indocyanine Green, ICG

Brief 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.

Interventions

PROCEDURESurgical removal of breast cancer and lymph nodes

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.

Sponsors

U.S. National Science Foundation
CollaboratorFED
Ss. Cyril and Methodius University of Skopje, Macedonia
CollaboratorUNKNOWN
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Positive lymph node detection with custom sensorsThe sample removed from the patient will be promptly imaged using our sensor, with the imaging process expected to last between 3 to 5 minutes for each sample.This study aims to determine the accuracy and reliability of our novel imaging technologies in identifying cancer-affected sentinel lymph nodes in breast cancer patients. Initially, we will utilize the NIR fluorescence from ICG to identify the location of lymph nodes in resected ex vivo samples. Following this, the identified lymph nodes will be exposed to UV light to detect any inherent autofluorescence. Once the imaging study is completed, a pathologist will examine all the surgically removed samples to determine whether there is metastasis in the lymph nodes, thereby establishing the definitive diagnosis.

Countries

North Macedonia

Contacts

Primary ContactViktor Gruev, PhD
vgruev@illinois.edu+1.267.847.4020
Backup ContactGoran Kondov, MD
kondov@yahoo.com+389.70.252010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026