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Intraoperative Evaluation of Axillary Lymphatics

NCT05094102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-13

Study results available
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Summary

This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.

Conditions

Interventions

DEVICE

OnLume Imaging System

for fluorescence-guided surgery with ICG dye

DRUG

Indocyanine green

Indocyanine green is a cyanine dye used in medical diagnostics

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • OnLume Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Heather B Neuman, MD, MS, FACS · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-04-27
Completion
2023-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05094102 on ClinicalTrials.gov