Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
North Macedonia
Study Type
Interventional
Intervention
Multispectral imager
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, sentynel lymph node, fluorescence imaging
Eligibility Criteria
Inclusion Criteria:
- early or progressive stage of breast cancer
- able to understand and willing to sign a written informed consent document
Exclusion Criteria:
- inflammatory cancerous tissue
- pregnant women
- history of allergic reactions to iodide or seafood allergy
- sentinel lymph nodes were not detected with radiocolloid and static gamma camera
- patients have previous breast surgery
- patients who were unwilling to enter the study
Sites / Locations
- University Clinic Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multispectral imaging device
Arm Description
Bio-inspired multispectral imaging device will be used to record fluorescence signals emited by dyes (Indocyanine green and methylene blue) routinely used for visual identification of sentinel lymph nodes per current standard of care worldwide.
Outcomes
Primary Outcome Measures
Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
The patient will be admitted to the hospital one day before the surgery and will be treated without deviating from normal operating procedures for this surgical procedure. The patient will be first administered radiocolloid tracer per current standard of care and scanned with a double-headed SPECT gamma camera to locate sentinel lymph nodes (SLN).
The patient is moved to the operating room next. After the patient undergoes anesthesia, methylene blue and indocyanine green will be administered. The surgeon will look to locate radioactive activity and coloration from methylene blue and indocyanine green.
While the surgeon is locating the SLN in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the multispectral camera. After the location of the sentinel lymph node, the surgeon will resect this tissue and with a handheld gamma probe will test for accumulation of the radio tracer.
Secondary Outcome Measures
Full Information
NCT ID
NCT03619967
First Posted
July 17, 2018
Last Updated
May 24, 2022
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Ss. Cyril and Methodius University of Skopje, Macedonia
1. Study Identification
Unique Protocol Identification Number
NCT03619967
Brief Title
Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Official Title
Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Ss. Cyril and Methodius University of Skopje, Macedonia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images.
To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.
Detailed Description
Per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. Initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. While the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera.
All resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. Results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, sentynel lymph node, fluorescence imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Experimental: Arm 1: Multispectral Imaging Per current standard of care for patients with breast cancer, three different tracers will be injected in the patient: technetium radiocolloid, indocyanine green and methylene blue. The surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. During this same time period, fluorescent signals from the underarm surgical wound site will be recorded with the bio-inspired multispectral camera.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multispectral imaging device
Arm Type
Experimental
Arm Description
Bio-inspired multispectral imaging device will be used to record fluorescence signals emited by dyes (Indocyanine green and methylene blue) routinely used for visual identification of sentinel lymph nodes per current standard of care worldwide.
Intervention Type
Device
Intervention Name(s)
Multispectral imager
Intervention Description
Device: Bio-inspired multispectral imager
-Manufactured at University of Illinois at Urbana Champaign
Primary Outcome Measure Information:
Title
Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
Description
The patient will be admitted to the hospital one day before the surgery and will be treated without deviating from normal operating procedures for this surgical procedure. The patient will be first administered radiocolloid tracer per current standard of care and scanned with a double-headed SPECT gamma camera to locate sentinel lymph nodes (SLN).
The patient is moved to the operating room next. After the patient undergoes anesthesia, methylene blue and indocyanine green will be administered. The surgeon will look to locate radioactive activity and coloration from methylene blue and indocyanine green.
While the surgeon is locating the SLN in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the multispectral camera. After the location of the sentinel lymph node, the surgeon will resect this tissue and with a handheld gamma probe will test for accumulation of the radio tracer.
Time Frame
Up to 1 week after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
early or progressive stage of breast cancer
able to understand and willing to sign a written informed consent document
Exclusion Criteria:
inflammatory cancerous tissue
pregnant women
history of allergic reactions to iodide or seafood allergy
sentinel lymph nodes were not detected with radiocolloid and static gamma camera
patients have previous breast surgery
patients who were unwilling to enter the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Gruev, PhD
Organizational Affiliation
UIUC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Hospital
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
12. IPD Sharing Statement
Plan to Share IPD
No
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Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
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