Filter Results

Clinical Studies

Open

Closed for Enrollment

  • A Mayo-Designed Nonmetallic, Ultrasound-Detectable Twinkling Marker for Metastatic Axillary Lymph Nodes in Breast Cancer (TWINKLEMARK) Rochester, Minn.

    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.
  • A Phase 1 Study in Patients with Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Ultrasound Twinkling Marker Observed for Sonographic Targeting (UTMost Trial) (UTMost) Rochester, Minn.

    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.
  • A Phase 2 Study In Patients With Clinically Node-Positive Breast Cancer To Assess The Safety, Ultrasound Conspicuity, And Migration Of An Optimized Ultrasound Twinkling Marker Observed For Sonographic Targeting (UTMOST2 Trial) Rochester, Minn. This phase II trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.
  • Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study (CASTLE) Rochester, Minn.

    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.
  • Investigation of Ultrasound Decorrelation Imaging Techniques to Improve Conspicuity of Biopsy Clips in Patients with Breast Cancer and Locally Advanced Disease to Axillary Lymph Nodes Rochester, Minn.

    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.
  • Use of henna to mark the skin Rochester, Minn.

    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.
  • ZTE MRI Pulse Sequence Use for Visualization of Bone Cement, Breast Biopsy Markers Rochester, Minn.

    The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
.