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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316795
• Other study ID #: 201302102
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of Breast
• Cancer of the Breast
• Malignant Melanoma
• Melanoma

Intervention

Procedure:
• Sentinel lymph node biopsy

Device:
• Goggle-based device with light-emitting diodes (LED)

Drug:
• Indocynanine Green
This is a infrared fluorescence imaging contrast agent

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?"	At the time of the biopsy procedure (approximately 1.5 hours)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine