Clinical trial NCT02316795: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Cancer of Breast
Cancer of the Breast
Melanoma
Malignant Melanoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: 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
timeFrame: At the time of the biopsy procedure (approximately 1.5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan C Fields, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.