Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

NCT03619967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-05-25

No results posted yet for this study

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

Interventions

DEVICE

Multispectral imager

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

Sponsors & Collaborators

  • Ss. Cyril and Methodius University of Skopje, Macedonia

    collaborator UNKNOWN
  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Viktor Gruev, PhD · UIUC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2022-05-25
Completion
2022-05-25

Countries

  • North Macedonia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619967 on ClinicalTrials.gov