Study Results
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View full resultsBasic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2022-05-05
2023-04-27
Brief Summary
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Detailed Description
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In this prospective study, breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.
The standard of care (blue dye) will be used for clinical care while the OnLume Imaging System is being used to determine feasibility of the product.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Axillary Surgery
Breast cancer patients undergoing SLN biopsy (n=0-20) or axillary lymph node dissection (n=0-15) will be enrolled to undergo standard of care axillary reverse mapping (ARM) using isosulfan blue dye. Participants will also receive ICG injection with visualization through the OnLume Imaging System to allow comparison of blue dye versus ICG lymphatic identification.
OnLume Imaging System
for fluorescence-guided surgery with ICG dye
Indocyanine green
Indocyanine green is a cyanine dye used in medical diagnostics
Interventions
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OnLume Imaging System
for fluorescence-guided surgery with ICG dye
Indocyanine green
Indocyanine green is a cyanine dye used in medical diagnostics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer requiring surgical lymph node evaluation either by sentinel lymph node biopsy or axillary lymph node dissection
* Surgery at University of Wisconsin Hospital and Clinic
Exclusion Criteria
* Unable to provide informed consent
* Allergy to indocyanine green
* Patients with clinically positive lymph nodes undergoing sentinel lymph node biopsy, with or without axillary lymph node dissection, after neoadjuvant chemotherapy
18 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
OnLume Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Heather B Neuman, MD, MS, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2020-0939
Identifier Type: OTHER
Identifier Source: secondary_id
A539713
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/SURG ONC
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 11/3/2022
Identifier Type: OTHER
Identifier Source: secondary_id
UW20058
Identifier Type: -
Identifier Source: org_study_id
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