Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study
James W Jakub, Gina K Hesley, Nicholas B Larson, Michael J Yaszemski, A Lee Miller 2nd, James F Greenleaf, Matthew W Urban, Christine U Lee, James W Jakub, Gina K Hesley, Nicholas B Larson, Michael J Yaszemski, A Lee Miller 2nd, James F Greenleaf, Matthew W Urban, Christine U Lee
Abstract
Purpose To evaluate the short-term safety of a nonmetallic twinkle marker and compare its conspicuity at color Doppler US with that of standard breast biopsy clips and radioactive seeds by using B-mode US in axillary lymph nodes. Materials and Methods This prospective study (November 2020-July 2021) of participants with node-positive breast cancer who completed chemotherapy involved placing a twinkle marker at the time of preoperative radioactive seed localization. A five-point scoring system (1 = easiest, 5 = most difficult) was used to rate the ease of identifying the clip, seed, and twinkle marker on postlocalization sonograms, mammograms, specimen radiographs, and gross pathologic specimens. Descriptive statistics were used. Results Eight women (mean age, 57 years ± 16 [SD]) were enrolled. The median scores for US conspicuity of each device were 3.9 (range, 3.7-5.0) for the radioactive seed, 2.4 (range, 1.0-5.0) for the clip, and 2.0 (range, 1.0-4.3) for the twinkle marker. In six of eight participants, the twinkle marker was the most identifiable at US. The seeds, clips, and twinkle markers were scored "very easy" to identify on seven of eight postlocalization mammograms. The surgeon retrieved all eight twinkle markers 1-3 days after localization. In all 16 interpretations, the seeds, clips, and twinkle markers were rated as very easy to identify on specimen radiographs. The clip was the most difficult device to identify at pathologic examination in all participants, and the twinkle marker was the easiest to identify in seven of eight participants. Conclusion This pilot study demonstrates that the safety and ease of US detection of a twinkling tissue marker may be comparable to a biopsy clip. Keywords: Ultrasonography, US-Doppler, Breast, Localization, Surgery Clinical trial registration no. NCT04674852 © RSNA, 2022.
Keywords: Breast; Localization; Surgery; US-Doppler; Ultrasonography.
Conflict of interest statement
Disclosures of conflicts of interest: J.W.J. Royalties or licenses from Sorrento Therapeutics; patent co-inventor on a pending patent application for the Twinkling Marker (PCT patent application no. US2020/051844); member of the Melanoma Surgical Advisory Board for Novartis Oncology (May 2020); member of the Corporate Relations Committee for the American Society of Breast Surgeons (voluntary, unpaid position). G.K.H. Patent co-inventor on a pending application on the Twinkling Marker (U.S. patent Application No. 17/398 778). N.B.L. No relevant relationships. M.J.Y. Patent co-inventor on a pending patent application for the Twinkling Marker (PCT patent application no. US2020/051844). A.L.M. Patent co-inventor on a pending patent application for the Twinkling Marker (PCT patent application no. US2020/051844). J.F.G. Patent co-inventor on a pending patent application for the Twinkling Marker (PCT patent application no. US2020/051844); patent co-inventor on a pending application on the Twinkling Marker (U.S. patent Application No. 17/398 778). W.U. U.S. continuation-in-part patent application (17/398 778) filed August 10, 2021 (also incorporates 2019-414 and 2020-192); provisional patent application (62/903 078) filed on September 20, 2019; PCT patent application (PCT/US2020/051844), filed on September 21, 2020 (primary, with 2020-192 as secondary); U.S. patent application (17/762,018) filed on March 18, 2022; European patent application (20786193.1) filed on March 31, 2022; U.S. continuation-in-part patent application (17/398 778) filed on August 10, 2021 (also incorporates 2020-192 and 2021-198). C.U.L. Co–primary investigator on internal grant from the Mayo Clinic Center of Individualized Medicine Imaging Biomarkers Program, no conflicting relationships, activities, or employment with this funding source; patent co-inventor on a pending patent application on the Twinkling Marker (PCT patent Application No. US2020/051844); patent co-inventor on a pending application on the Twinkling Marker (U.S. patent Application No. 17/398 778).
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Source: PubMed