Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276439
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-15
Brief Title:
Intraoperative Imaging of Lymph Nodes
Sponsor:
University of Illinois at Urbana-Champaign
Organization:
University of Illinois at Urbana-Champaign
Study Overview
Official Title:
Intraoperative Imaging of Indocyanine Green for Sentinel Lymph Node Mapping
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 were drawing inspiration from the mantis shrimps 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None