Intraoperative Imaging of Lymph Nodes

NCT ID: NCT06276439

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2026-02-19

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Positive lymph node detection with bioinspired sensor

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.

Surgical removal of breast cancer and lymph nodes

Intervention Type: PROCEDURE

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.

Positive lymph node detection with highly sensitive imaging sensor

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.

Surgical removal of breast cancer and lymph nodes

Intervention Type: PROCEDURE

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.

Interventions

Surgical 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

U.S. National Science Foundation

FED

Sponsor Role: collaborator

Ss. Cyril and Methodius University of Skopje, Macedonia

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viktor Gruev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Urbana Champaign

Locations

University Clinic Hospital

Skopje, , North Macedonia

Site Status: RECRUITING

Countries

North Macedonia

Central Contacts

Viktor Gruev, PhD

Role: CONTACT

vgruev@illinois.edu

+1.267.847.4020

Goran Kondov, MD

Role: CONTACT

kondov@yahoo.com

+389.70.252010

Facility Contacts

Viktor Gruev, PhD

Role: primary

vgruev@illinois.edu

+1.267.847.4020

Goran Kondov, MD, PHD

Role: backup

kondov@yahoo.com

+389 70 252010

References

Blair S, Garcia M, Davis T, Zhu Z, Liang Z, Konopka C, Kauffman K, Colanceski R, Ferati I, Kondov B, Stojanoski S, Todorovska MB, Dimitrovska NT, Jakupi N, Miladinova D, Petrusevska G, Kondov G, Dobrucki WL, Nie S, Gruev V. Hexachromatic bioinspired camera for image-guided cancer surgery. Sci Transl Med. 2021 May 5;13(592):eaaw7067. doi: 10.1126/scitranslmed.aaw7067.

Reference Type: BACKGROUND

PMID: 33952675 (View on PubMed)

Chen C, Wang Z, Wu J, Deng Z, Zhang T, Zhu Z, Jin Y, Lew B, Srivastava I, Liang Z, Nie S, Gruev V. Bioinspired, vertically stacked, and perovskite nanocrystal-enhanced CMOS imaging sensors for resolving UV spectral signatures. Sci Adv. 2023 Nov 3;9(44):eadk3860. doi: 10.1126/sciadv.adk3860. Epub 2023 Nov 3.

Reference Type: BACKGROUND

PMID: 37922355 (View on PubMed)

Other Identifiers

IRB23-0314

Identifier Type: -

Identifier Source: org_study_id