Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

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.

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Key information

Conditions

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

Age range

17 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Hospital

Skopje, 1000, North Macedonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multispectral imager

Device

Device: Bio-inspired multispectral imager

-Manufactured at University of Illinois at Urbana Champaign

Primary outcomes

Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.

Time frame: Up to 1 week after surgery

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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

Ss. Cyril and Methodius University of Skopje

Registry information

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Aug 8, 2018
Registry last updated: May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed