This phase I 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
Undergo mammography
Undergo surgical resection of the lymph node as part of standard care.
Undergo ultrasound imaging. Ultrasound images will be evaluated for presence and visibility/conspicuity of the twinkling marker.
Undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGConspicuity of the optimized Mayo-developed twinkling marker
Assessed by the visibility/conspicuity of the twinkling marker under ultrasound occurring as part of standard of care \[neoadjuvant systemic therapy (NST)\].
Time frame: Baseline up to final pre-operative imaging before surgery; generally 6-9 months
Migration of the optimized Mayo-developed twinkling marker
Will be determined from surgical and pathology documentation after node resection
Time frame: At time of surgery (baseline)
Incidence of adverse events (safety of twinkling marker)
Adverse events (AEs) are defined as any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research. AEs will be assessed as Mild (events require minimal or no treatment and do not interfere with the participant's daily activities); Moderate (events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning); or Severe (Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating).Of note, the term "severe" does not necessarily equate to "serious".
Time frame: Baseline up to final visit before surgery; generally 6-9 months
Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit
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