Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

NCT03619967 | Completed

• 1 other identifier: 18947
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; sentynel lymph node; fluorescence imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 week after surgery

Study Arms (1)

Multispectral imaging device

EXPERIMENTAL

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.

Device: Multispectral imager

Interventions

Multispectral imager DEVICE

Device: Bio-inspired multispectral imager -Manufactured at University of Illinois at Urbana Champaign

Multispectral imaging device

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• early or progressive stage of breast cancer
• able to understand and willing to sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Ss. Cyril and Methodius University of Skopje, Macedonia: collaborator

Study Sites (1)

University Clinic Hospital

Skopje, 1000, North Macedonia

Location

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

  UIUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 8, 2018
• Study Start: July 20, 2018
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)