Intraoperative Imaging of Lymph Nodes

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Surgical removal of breast cancer and lymph nodes

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06276439

IRB23-0314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

Positive lymph node detection with bioinspired sensor

Description:

We will assess the effectiveness of our bioinspired sensor in identifying affected lymph nodes in ex vivo samples. This innovative sensor integrates spectral filters and vertically aligned photodiodes, mirroring the visual capabilities of the mantis shrimp, to simultaneously capture intrinsic UV fluorescence and externally introduced NIR fluorescence from ICG. To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth.

Treatment:

Procedure: Surgical removal of breast cancer and lymph nodes

Positive lymph node detection with highly sensitive imaging sensor

Description:

We will evaluate the performance of our sensor, characterized by low noise and high quantum efficiency, in detecting compromised lymph nodes in ex vivo samples. This advanced sensor combine spectral filters and low noise photodiodes, enabling the simultaneous detection of natural UV fluorescence and induced NIR fluorescence from ICG. To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth.

Treatment:

Procedure: Surgical removal of breast cancer and lymph nodes