Intraoperative Imaging of Lymph Nodes

NCT06276439 | Recruiting

• 1 other identifier: IRB23-0314
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Positive lymph node detection with custom sensors

  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.

  The 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.

Study Arms (2)

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.

Procedure: Surgical removal of breast cancer and lymph nodes

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.

Procedure: Surgical removal of breast cancer and lymph nodes

Interventions

Surgical removal of breast cancer and lymph nodes 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 bioinspired sensor; Positive lymph node detection with highly sensitive imaging sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• early or progressive stage of breast cancer who needs to be treated with breast surgery

You may not qualify if:

• pregnant women
• previous breast cancer surgery
• history of allergic reactions to iodide or seafood allergy.
• man

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• U.S. National Science Foundation: collaborator
• Ss. Cyril and Methodius University of Skopje, Macedonia: collaborator

Study Sites (1)

University Clinic Hospital

Skopje, 1000, North Macedonia

RECRUITING

Related Publications (2)

• 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.

  PMID: 33952675 BACKGROUND

• 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.

  PMID: 37922355 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Viktor Gruev, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktor Gruev, PhD

CONTACT

+1.267.847.4020; vgruev@illinois.edu

Goran Kondov, MD

CONTACT

+389.70.252010; kondov@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 26, 2024
• Study Start: February 19, 2024
• Primary Completion: March 30, 2025
• Study Completion: February 19, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)