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Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

Primary Purpose

Breast Cancer, Cancer of Breast, Cancer of the Breast

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sentinel lymph node biopsy
Goggle-based device with light-emitting diodes (LED)
Indocynanine Green
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy.
  • Negative nodal basin clinical exam.
  • At least 18 years of age.
  • Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Contraindications for surgery.
  • Receiving any investigational agents.
  • History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy.
  • Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant.
  • Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ICG dye.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLN biopsy with ICG injection

Arm Description

During the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure. After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed.

Outcomes

Primary Outcome Measures

Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN
After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols. Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid. Fluorescence imaging results will be classified in relation to the "true" status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN. The main data point collected is "Do ICG-identified node (s) have extra-corporeal gamma activity?"

Secondary Outcome Measures

Full Information

First Posted
December 4, 2014
Last Updated
September 23, 2019
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02316795
Brief Title
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
Official Title
Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer of Breast, Cancer of the Breast, Melanoma, Malignant Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLN biopsy with ICG injection
Arm Type
Experimental
Arm Description
During the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure. After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed.
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node biopsy
Other Intervention Name(s)
SLN biopsy
Intervention Type
Device
Intervention Name(s)
Goggle-based device with light-emitting diodes (LED)
Intervention Type
Drug
Intervention Name(s)
Indocynanine Green
Other Intervention Name(s)
ICG
Intervention Description
This is a infrared fluorescence imaging contrast agent
Primary Outcome Measure Information:
Title
Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN
Description
After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols. Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid. Fluorescence imaging results will be classified in relation to the "true" status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN. The main data point collected is "Do ICG-identified node (s) have extra-corporeal gamma activity?"
Time Frame
At the time of the biopsy procedure (approximately 1.5 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy. Negative nodal basin clinical exam. At least 18 years of age. Able to understand and willing to sign a written informed consent document. Exclusion Criteria: Contraindications for surgery. Receiving any investigational agents. History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy. Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant. Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ICG dye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan C Fields, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23467534
Citation
Liu Y, Akers WJ, Bauer AQ, Mondal S, Gullicksrud K, Sudlow GP, Culver JP, Achilefu S. Intraoperative detection of liver tumors aided by a fluorescence goggle system and multimodal imaging. Analyst. 2013 Apr 21;138(8):2254-7. doi: 10.1039/c3an00165b.
Results Reference
background
PubMed Identifier
21496565
Citation
Liu Y, Bauer AQ, Akers WJ, Sudlow G, Liang K, Shen D, Berezin MY, Culver JP, Achilefu S. Hands-free, wireless goggles for near-infrared fluorescence and real-time image-guided surgery. Surgery. 2011 May;149(5):689-98. doi: 10.1016/j.surg.2011.02.007.
Results Reference
background
PubMed Identifier
23728180
Citation
Liu Y, Njuguna R, Matthews T, Akers WJ, Sudlow GP, Mondal S, Tang R, Gruev V, Achilefu S. Near-infrared fluorescence goggle system with complementary metal-oxide-semiconductor imaging sensor and see-through display. J Biomed Opt. 2013 Oct;18(10):101303. doi: 10.1117/1.JBO.18.10.101303.
Results Reference
background
PubMed Identifier
23747795
Citation
Liu Y, Zhao YM, Akers W, Tang ZY, Fan J, Sun HC, Ye QH, Wang L, Achilefu S. First in-human intraoperative imaging of HCC using the fluorescence goggle system and transarterial delivery of near-infrared fluorescent imaging agent: a pilot study. Transl Res. 2013 Nov;162(5):324-331. doi: 10.1016/j.trsl.2013.05.002. Epub 2013 Jun 5.
Results Reference
background
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma

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