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In Vivo Evaluation of Lymph Nodes Using Quantitative Ultrasound

Clinical Trial Details

The purpose of this study is to determine the effectiveness of a new ultrasound technique to detect cancer and/or other abnormalities in lymph nodes, small bean-shaped structures that are part of the body's immune system. Participants in this study will have at least one lymph node that may be larger than normal. 

The routine care for this is to get a biopsy, a procedure to remove a piece of tissue or a sample of cells from the body so that it can be tested in a laboratory, done through a fine needle inserted in the lymph node (US-FNA biopsy) while also undergoing an ultrasound around the area to test. An ultrasound is a painless non-invasive way to get a picture of areas inside the body using sound waves. The doctor (pathologist) will test the tissue samples obtained under a microscope to see if cancer cells or any abnormalities are present. You will receive this procedure as part of your care even if you do not participate in the study. Using these existing tests, it is possible that some abnormal or cancer cells remain in parts of the lymph nodes that were not examined under a microscope. 

This study will develop and evaluate a clinical scanner with novel QUS-based software which will markedly improve the efficiency and effectiveness of pathologists, surgeons, and other clinicians who perform in situ LN detection and evaluation. It will lead to a next generation clinical ultrasound instrument capable of reliably detecting LNs and metastases in LNs in the examination room, but also in the operating room or in excised specimen in the pathology laboratory.
The ultrasound (US) machine (logiq E10) is approved by the U.S. Food and Drug Administration (FDA) for clinical use. The quantitative ultrasound (QUS) imaging software used in this study is not approved by the FDA and therefore is considered to be experimental. 
Key Eligibility: 

Open to men and women above the age of 18 who have superficial lymphadenopathy and who need to undergo standard, medically required LN evaluation by conventional ultrasonography and ultrasound guided FNA.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jincy Koshy
646-962-2964

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2306026152

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease