Christine U. Lee, M.D., Ph.D.

This is a Phase 0 clinical trial to evaluate a twinkling biopsy marker (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type:  Provisional) for ultrasound conspicuity in patients with breast cancer and locally advanced disease involving the axillary lymph nodes.

In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally move in patients who are receiving neoadjuvant systemic therapy for breast cancer with metastasis to the lymph nodes under the arm.

Lymphaticovenous anstomosis is an effective surgery to treat lymphedema in the upper extremities secondary to cancer treatment. A crucial step is to identify patent lymphatic channels. Contrast enhanced ultrasound (CEUS) with intradermal injection of microbubbles is a promising method for lymphatic mapping in the upper extrmeities with lymphedema. The goals of the study are(1) to establish the preferred FDA approved microbubble agent (Lumason, Optison, Definity) for CEUS lymphatic mapping, (2) to identify lymphatic channels with CEUS and high-frequency ultrasound in patients receiving lymphaticovenous anastomosis surgery for upper extremity lymphedema, (3) and to validate the use of shear wave elastography for detecting improving in lymphedema prospectively.

The purpose of this study is to evaluate and optimize the performance of the ultrasound decorrelation imaging technique on 10 clinical patients where ultrasonographic clip detection is needed.

The skin is commonly marked with an ink-based pen prior to and during ultrasound guided procedures. However, ink markings on the skin can affected by routine skip preperation. Additional limitations include its durability if the marking needs to last multiple days and its inability to write over ultrasound gel.

This is a feasibility study evaluating henna's ability to mark the skin under specified conditions, and it will not be evaluating the safety or efficacy for a medical purpose. As a result, henna is not listed in this application as a study drug or device. Henna will be applied on the human skin over ultrasound gel. Then its durability and resistence to alcohol-based antiseptic solutions containing chlorhexidine gluconate will be evaluated.

Following further discussion with ORRS, it was determined this is a feasibility study, which is not evaluating the safety or efficacy of henna for a medical purpose. Therefore an IND or IDE is not required. The IRB application has been updated accordingly.