Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe
Background Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising resu...
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| Veröffentlicht in: | Journal of surgical oncology 2019-12, Vol.120 (8), p.1391-1396 |
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| creator | Taruno, Kanae Kurita, Tomoko Kuwahata, Akihiko Yanagihara, Keiko Enokido, Katsutoshi Katayose, Yoshihisa Nakamura, Seigo Takei, Hiroyuki Sekino, Masaki Kusakabe, Moriaki |
| description | Background
Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection.
Methods
Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan.
Results
Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%.
Conclusion
This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method. |
| doi_str_mv | 10.1002/jso.25747 |
| format | Article |
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Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection.
Methods
Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan.
Results
Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%.
Conclusion
This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.</description><identifier>ISSN: 0022-4790</identifier><identifier>EISSN: 1096-9098</identifier><identifier>DOI: 10.1002/jso.25747</identifier><identifier>PMID: 31667855</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biopsy ; Breast cancer ; Breast Neoplasms - pathology ; Clinical trials ; Coloring Agents ; Contrast Media ; Dextrans ; Female ; Ferric Compounds ; Humans ; Indigo Carmine ; Lymphatic system ; magnetic probe ; Magnetite Nanoparticles ; Magnetometry - instrumentation ; Middle Aged ; Nanoparticles ; Prospective Studies ; Radiopharmaceuticals ; Sentinel Lymph Node - pathology ; sentinel lymph node biopsy ; Sentinel Lymph Node Biopsy - methods ; superparamagnetic iron oxide</subject><ispartof>Journal of surgical oncology, 2019-12, Vol.120 (8), p.1391-1396</ispartof><rights>2019 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4747-7c197ba4e1dcb1970f2a896f6d9f1428bece5c6eaecb117a355406bb0dd1ab503</citedby><cites>FETCH-LOGICAL-c4747-7c197ba4e1dcb1970f2a896f6d9f1428bece5c6eaecb117a355406bb0dd1ab503</cites><orcidid>0000-0002-7754-1548</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjso.25747$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjso.25747$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31667855$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Taruno, Kanae</creatorcontrib><creatorcontrib>Kurita, Tomoko</creatorcontrib><creatorcontrib>Kuwahata, Akihiko</creatorcontrib><creatorcontrib>Yanagihara, Keiko</creatorcontrib><creatorcontrib>Enokido, Katsutoshi</creatorcontrib><creatorcontrib>Katayose, Yoshihisa</creatorcontrib><creatorcontrib>Nakamura, Seigo</creatorcontrib><creatorcontrib>Takei, Hiroyuki</creatorcontrib><creatorcontrib>Sekino, Masaki</creatorcontrib><creatorcontrib>Kusakabe, Moriaki</creatorcontrib><title>Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe</title><title>Journal of surgical oncology</title><addtitle>J Surg Oncol</addtitle><description>Background
Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection.
Methods
Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan.
Results
Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%.
Conclusion
This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - pathology</subject><subject>Clinical trials</subject><subject>Coloring Agents</subject><subject>Contrast Media</subject><subject>Dextrans</subject><subject>Female</subject><subject>Ferric Compounds</subject><subject>Humans</subject><subject>Indigo Carmine</subject><subject>Lymphatic system</subject><subject>magnetic probe</subject><subject>Magnetite Nanoparticles</subject><subject>Magnetometry - instrumentation</subject><subject>Middle Aged</subject><subject>Nanoparticles</subject><subject>Prospective Studies</subject><subject>Radiopharmaceuticals</subject><subject>Sentinel Lymph Node - pathology</subject><subject>sentinel lymph node biopsy</subject><subject>Sentinel Lymph Node Biopsy - methods</subject><subject>superparamagnetic iron oxide</subject><issn>0022-4790</issn><issn>1096-9098</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1O3DAURi1UBFPaRV-gstQNXQTsxInjZYVoAYFY0K4j27lhPHLs1J4A8xC8cy8MZYHExn_fuce2LiFfODvijJXHqxyPyloKuUMWnKmmUEy1H8gCs7IQUrF98jHnFWNMqUbskf2KN41s63pBHq9mv3YWwhoStd4FZ7Wn6-RwjIFmDFwAT_1mnJY0xB6ocXHKGzpnF25pnidIk0561LcB0ERdwrr44JAMOkTM8NRDpjr0VKPiDnVL3CzB9_S1bErRwCeyO2if4fPLfED-_Dz9fXJWXF7_Oj_5cVlYgb8spOVKGi2A99bgkg2lblUzNL0auChbAxZq24AGjLnUVV0L1hjD-p5rU7PqgBxuvXjr3xnyuhtdtuC9DhDn3JUVZ7IUJZeIfnuDruKcAr7uiZKtYLISSH3fUjbFnBMM3ZTcqNOm46x76lGHPeqee4Ts1xfjbEboX8n_TUHgeAvcOw-b903dxc31VvkPDeaeqg</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Taruno, Kanae</creator><creator>Kurita, Tomoko</creator><creator>Kuwahata, Akihiko</creator><creator>Yanagihara, Keiko</creator><creator>Enokido, Katsutoshi</creator><creator>Katayose, Yoshihisa</creator><creator>Nakamura, Seigo</creator><creator>Takei, Hiroyuki</creator><creator>Sekino, Masaki</creator><creator>Kusakabe, Moriaki</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7754-1548</orcidid></search><sort><creationdate>20191201</creationdate><title>Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe</title><author>Taruno, Kanae ; Kurita, Tomoko ; Kuwahata, Akihiko ; Yanagihara, Keiko ; Enokido, Katsutoshi ; Katayose, Yoshihisa ; Nakamura, Seigo ; Takei, Hiroyuki ; Sekino, Masaki ; Kusakabe, Moriaki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4747-7c197ba4e1dcb1970f2a896f6d9f1428bece5c6eaecb117a355406bb0dd1ab503</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - pathology</topic><topic>Clinical trials</topic><topic>Coloring Agents</topic><topic>Contrast Media</topic><topic>Dextrans</topic><topic>Female</topic><topic>Ferric Compounds</topic><topic>Humans</topic><topic>Indigo Carmine</topic><topic>Lymphatic system</topic><topic>magnetic probe</topic><topic>Magnetite Nanoparticles</topic><topic>Magnetometry - instrumentation</topic><topic>Middle Aged</topic><topic>Nanoparticles</topic><topic>Prospective Studies</topic><topic>Radiopharmaceuticals</topic><topic>Sentinel Lymph Node - pathology</topic><topic>sentinel lymph node biopsy</topic><topic>Sentinel Lymph Node Biopsy - methods</topic><topic>superparamagnetic iron oxide</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Taruno, Kanae</creatorcontrib><creatorcontrib>Kurita, Tomoko</creatorcontrib><creatorcontrib>Kuwahata, Akihiko</creatorcontrib><creatorcontrib>Yanagihara, Keiko</creatorcontrib><creatorcontrib>Enokido, Katsutoshi</creatorcontrib><creatorcontrib>Katayose, Yoshihisa</creatorcontrib><creatorcontrib>Nakamura, Seigo</creatorcontrib><creatorcontrib>Takei, Hiroyuki</creatorcontrib><creatorcontrib>Sekino, Masaki</creatorcontrib><creatorcontrib>Kusakabe, Moriaki</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of surgical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Taruno, Kanae</au><au>Kurita, Tomoko</au><au>Kuwahata, Akihiko</au><au>Yanagihara, Keiko</au><au>Enokido, Katsutoshi</au><au>Katayose, Yoshihisa</au><au>Nakamura, Seigo</au><au>Takei, Hiroyuki</au><au>Sekino, Masaki</au><au>Kusakabe, Moriaki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe</atitle><jtitle>Journal of surgical oncology</jtitle><addtitle>J Surg Oncol</addtitle><date>2019-12-01</date><risdate>2019</risdate><volume>120</volume><issue>8</issue><spage>1391</spage><epage>1396</epage><pages>1391-1396</pages><issn>0022-4790</issn><eissn>1096-9098</eissn><abstract>Background
Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node‐negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection.
Methods
Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan.
Results
Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%.
Conclusion
This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31667855</pmid><doi>10.1002/jso.25747</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-7754-1548</orcidid></addata></record> |
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| ispartof | Journal of surgical oncology, 2019-12, Vol.120 (8), p.1391-1396 |
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| subjects | Adult Aged Aged, 80 and over Biopsy Breast cancer Breast Neoplasms - pathology Clinical trials Coloring Agents Contrast Media Dextrans Female Ferric Compounds Humans Indigo Carmine Lymphatic system magnetic probe Magnetite Nanoparticles Magnetometry - instrumentation Middle Aged Nanoparticles Prospective Studies Radiopharmaceuticals Sentinel Lymph Node - pathology sentinel lymph node biopsy Sentinel Lymph Node Biopsy - methods superparamagnetic iron oxide |
| title | Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe |
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