Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

NCT ID: NCT03619967

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-20
• Study Completion Date: 2022-05-25

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Multispectral imaging device

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.

Group Type: EXPERIMENTAL

Multispectral imager

Intervention Type: DEVICE

Device: Bio-inspired multispectral imager

-Manufactured at University of Illinois at Urbana Champaign

Interventions

Multispectral imager

Device: Bio-inspired multispectral imager

-Manufactured at University of Illinois at Urbana Champaign

Intervention Type: DEVICE

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ss. Cyril and Methodius University of Skopje, Macedonia

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Viktor Gruev, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Gruev, PhD

Role: PRINCIPAL_INVESTIGATOR

UIUC

Locations

University Clinic Hospital

Skopje, , North Macedonia

Countries

North Macedonia

Other Identifiers

18947

Identifier Type: -

Identifier Source: org_study_id