Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

Breast Cancer Clinical Trial

Official title:

Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619967
• Other study ID #: 18947
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
North Macedonia	University Clinic Hospital	Skopje

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Ss. Cyril and Methodius University of Skopje, Macedonia

Country where clinical trial is conducted

North Macedonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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