Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial)
Purpose Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT i...
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| Veröffentlicht in: | Clinical neuroradiology (Munich) 2024-12, Vol.34 (4), p.929-937 |
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| creator | Ståhl, Fredrik Almqvist, Håkan Aspelin, Åsa Kolloch, Jens Ghalamkari, Odett Gontu, Vamsi Schäfer, Dirk van de Haar, Peter Engel, Klaus-Jürgen van Nijnatten, Fred Holmberg, Åke Mazya, Michael V. Söderman, Michael Delgado, Anna Falk |
| description | Purpose
Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT in the interventional suite to reference standard CT in stroke patients.
Methods
A prospective single-center study enrolled consecutive participants with ischemic or hemorrhagic stroke. The hemorrhage detection accuracy, per-region ASPECTS accuracy and subjective image quality (Likert scales for gray-white matter differentiation, structure perception and artifacts) were assessed by three neuroradiologists blinded to clinical data on dual-layer cone-beam CT 75 keV monoenergetic images compared to CT. Objective image quality was assessed by region-of-interest metrics. Non-inferiority for hemorrhage detection and ASPECTS accuracy was determined by the exact binomial test with a one-sided lower performance boundary prospectively set to 80% (98.75% CI).
Results
27 participants were included (74 years ± 9; 19 female) in the hyperacute or acute stroke phase. One reader missed a small bleeding, but all hemorrhages were detected in the majority analysis (100% accuracy, CI lower boundary 86%,
p
= 0.002). ASPECTS majority analysis showed 90% accuracy (CI lower boundary 85%,
p
|
| doi_str_mv | 10.1007/s00062-024-01439-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_878398</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3128433060</sourcerecordid><originalsourceid>FETCH-LOGICAL-c394t-284082d825afabe905bcbba98a9fe6624badc840fad741a716d1c077c46c1de73</originalsourceid><addsrcrecordid>eNp9kt1u0zAUxyMEYtPYC3CBLHEzLjzsOIkTbhB0H1SqAKmdxJ11kpy23hKn2E6hb7Nn2CPsyXDWUhgXXPnI53e-_1H0krNTzph86xhjWUxZnFDGE1FQ-SQ65HlWUJ4k8uneFsVBdOzcdcCZyIs0lc-jA1GwNGZpchjdTb3tbpCcr6HpwevOEG2IXyIZG492jWb4g4ZMe-2RXDltFuSsh4ZOYIOWnKHHyneWjDqD9CNCS0azdwTuby-0dZ5qQ5d9C4Z8tZ1bBVSvMbDLznoy9X29ISdDsc_405NLNGgferi__UYtbMi4hcVQcLpxHlsysxqaNy-iZ3NoHB7v3qPo6uJ8NvpEJ18ux6MPE1qJIvE0zhOWx3UepzCHEsPEZVWWUORQzDHL4qSEugrMHGqZcJA8q3nFpKySrOI1SnEU0W1e9wNXfalWVrdgN6oDrXZfN8FClctcFHng32_54GmxrsLqLDSPwh57jF6qRbdWnKdZuBMLGU52GWz3vUfnVatdhU0DBrveKcHyREohxIC-_ge97nobDhUoHkYPTDZQ8Zaqwvadxfm-G87UICO1lZEKMlIPMlLD3K_-nmMf8ls0ARC7xQSXWaD9U_s_aX8BIHPXuA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3128433060</pqid></control><display><type>article</type><title>Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial)</title><source>MEDLINE</source><source>SWEPUB Freely available online</source><source>Springer Nature - Complete Springer Journals</source><creator>Ståhl, Fredrik ; Almqvist, Håkan ; Aspelin, Åsa ; Kolloch, Jens ; Ghalamkari, Odett ; Gontu, Vamsi ; Schäfer, Dirk ; van de Haar, Peter ; Engel, Klaus-Jürgen ; van Nijnatten, Fred ; Holmberg, Åke ; Mazya, Michael V. ; Söderman, Michael ; Delgado, Anna Falk</creator><creatorcontrib>Ståhl, Fredrik ; Almqvist, Håkan ; Aspelin, Åsa ; Kolloch, Jens ; Ghalamkari, Odett ; Gontu, Vamsi ; Schäfer, Dirk ; van de Haar, Peter ; Engel, Klaus-Jürgen ; van Nijnatten, Fred ; Holmberg, Åke ; Mazya, Michael V. ; Söderman, Michael ; Delgado, Anna Falk</creatorcontrib><description>Purpose
Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT in the interventional suite to reference standard CT in stroke patients.
Methods
A prospective single-center study enrolled consecutive participants with ischemic or hemorrhagic stroke. The hemorrhage detection accuracy, per-region ASPECTS accuracy and subjective image quality (Likert scales for gray-white matter differentiation, structure perception and artifacts) were assessed by three neuroradiologists blinded to clinical data on dual-layer cone-beam CT 75 keV monoenergetic images compared to CT. Objective image quality was assessed by region-of-interest metrics. Non-inferiority for hemorrhage detection and ASPECTS accuracy was determined by the exact binomial test with a one-sided lower performance boundary prospectively set to 80% (98.75% CI).
Results
27 participants were included (74 years ± 9; 19 female) in the hyperacute or acute stroke phase. One reader missed a small bleeding, but all hemorrhages were detected in the majority analysis (100% accuracy, CI lower boundary 86%,
p
= 0.002). ASPECTS majority analysis showed 90% accuracy (CI lower boundary 85%,
p
< 0.001). Sensitivity was 66% (individual readers 67%, 69%, and 76%), specificity was 97% (97%, 96%, 89%). Subjective and objective image quality were inferior to CT.
Conclusion
In a small single-center cohort, dual-layer cone-beam CT showed non-inferior hemorrhage detection and ASPECTS accuracy to CT. Despite inferior image quality, the technique may be useful for stroke evaluation in the interventional suite.
Trial Registration Number
NCT04571099 (clinicaltrials.gov). Prospectively registered 2020-09-04.</description><identifier>ISSN: 1869-1439</identifier><identifier>ISSN: 1869-1447</identifier><identifier>EISSN: 1869-1447</identifier><identifier>DOI: 10.1007/s00062-024-01439-7</identifier><identifier>PMID: 39052054</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Accuracy ; Aged ; Aged, 80 and over ; Cone-Beam Computed Tomography - methods ; Female ; Hemorrhage ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neurology ; Neuroradiology ; Neurosurgery ; Original ; Original Article ; Prospective Studies ; Radiography, Interventional - methods ; Stroke ; Stroke - diagnostic imaging</subject><ispartof>Clinical neuroradiology (Munich), 2024-12, Vol.34 (4), p.929-937</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c394t-284082d825afabe905bcbba98a9fe6624badc840fad741a716d1c077c46c1de73</cites><orcidid>0000-0003-4389-5089 ; 0000-0002-0363-1284 ; 0000-0002-5941-7412 ; 0000-0002-0377-3506 ; 0000-0002-9690-0286</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00062-024-01439-7$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00062-024-01439-7$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39052054$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:159076029$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Ståhl, Fredrik</creatorcontrib><creatorcontrib>Almqvist, Håkan</creatorcontrib><creatorcontrib>Aspelin, Åsa</creatorcontrib><creatorcontrib>Kolloch, Jens</creatorcontrib><creatorcontrib>Ghalamkari, Odett</creatorcontrib><creatorcontrib>Gontu, Vamsi</creatorcontrib><creatorcontrib>Schäfer, Dirk</creatorcontrib><creatorcontrib>van de Haar, Peter</creatorcontrib><creatorcontrib>Engel, Klaus-Jürgen</creatorcontrib><creatorcontrib>van Nijnatten, Fred</creatorcontrib><creatorcontrib>Holmberg, Åke</creatorcontrib><creatorcontrib>Mazya, Michael V.</creatorcontrib><creatorcontrib>Söderman, Michael</creatorcontrib><creatorcontrib>Delgado, Anna Falk</creatorcontrib><title>Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial)</title><title>Clinical neuroradiology (Munich)</title><addtitle>Clin Neuroradiol</addtitle><addtitle>Clin Neuroradiol</addtitle><description>Purpose
Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT in the interventional suite to reference standard CT in stroke patients.
Methods
A prospective single-center study enrolled consecutive participants with ischemic or hemorrhagic stroke. The hemorrhage detection accuracy, per-region ASPECTS accuracy and subjective image quality (Likert scales for gray-white matter differentiation, structure perception and artifacts) were assessed by three neuroradiologists blinded to clinical data on dual-layer cone-beam CT 75 keV monoenergetic images compared to CT. Objective image quality was assessed by region-of-interest metrics. Non-inferiority for hemorrhage detection and ASPECTS accuracy was determined by the exact binomial test with a one-sided lower performance boundary prospectively set to 80% (98.75% CI).
Results
27 participants were included (74 years ± 9; 19 female) in the hyperacute or acute stroke phase. One reader missed a small bleeding, but all hemorrhages were detected in the majority analysis (100% accuracy, CI lower boundary 86%,
p
= 0.002). ASPECTS majority analysis showed 90% accuracy (CI lower boundary 85%,
p
< 0.001). Sensitivity was 66% (individual readers 67%, 69%, and 76%), specificity was 97% (97%, 96%, 89%). Subjective and objective image quality were inferior to CT.
Conclusion
In a small single-center cohort, dual-layer cone-beam CT showed non-inferior hemorrhage detection and ASPECTS accuracy to CT. Despite inferior image quality, the technique may be useful for stroke evaluation in the interventional suite.
Trial Registration Number
NCT04571099 (clinicaltrials.gov). Prospectively registered 2020-09-04.</description><subject>Accuracy</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Cone-Beam Computed Tomography - methods</subject><subject>Female</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neurology</subject><subject>Neuroradiology</subject><subject>Neurosurgery</subject><subject>Original</subject><subject>Original Article</subject><subject>Prospective Studies</subject><subject>Radiography, Interventional - methods</subject><subject>Stroke</subject><subject>Stroke - diagnostic imaging</subject><issn>1869-1439</issn><issn>1869-1447</issn><issn>1869-1447</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>D8T</sourceid><recordid>eNp9kt1u0zAUxyMEYtPYC3CBLHEzLjzsOIkTbhB0H1SqAKmdxJ11kpy23hKn2E6hb7Nn2CPsyXDWUhgXXPnI53e-_1H0krNTzph86xhjWUxZnFDGE1FQ-SQ65HlWUJ4k8uneFsVBdOzcdcCZyIs0lc-jA1GwNGZpchjdTb3tbpCcr6HpwevOEG2IXyIZG492jWb4g4ZMe-2RXDltFuSsh4ZOYIOWnKHHyneWjDqD9CNCS0azdwTuby-0dZ5qQ5d9C4Z8tZ1bBVSvMbDLznoy9X29ISdDsc_405NLNGgferi__UYtbMi4hcVQcLpxHlsysxqaNy-iZ3NoHB7v3qPo6uJ8NvpEJ18ux6MPE1qJIvE0zhOWx3UepzCHEsPEZVWWUORQzDHL4qSEugrMHGqZcJA8q3nFpKySrOI1SnEU0W1e9wNXfalWVrdgN6oDrXZfN8FClctcFHng32_54GmxrsLqLDSPwh57jF6qRbdWnKdZuBMLGU52GWz3vUfnVatdhU0DBrveKcHyREohxIC-_ge97nobDhUoHkYPTDZQ8Zaqwvadxfm-G87UICO1lZEKMlIPMlLD3K_-nmMf8ls0ARC7xQSXWaD9U_s_aX8BIHPXuA</recordid><startdate>20241201</startdate><enddate>20241201</enddate><creator>Ståhl, Fredrik</creator><creator>Almqvist, Håkan</creator><creator>Aspelin, Åsa</creator><creator>Kolloch, Jens</creator><creator>Ghalamkari, Odett</creator><creator>Gontu, Vamsi</creator><creator>Schäfer, Dirk</creator><creator>van de Haar, Peter</creator><creator>Engel, Klaus-Jürgen</creator><creator>van Nijnatten, Fred</creator><creator>Holmberg, Åke</creator><creator>Mazya, Michael V.</creator><creator>Söderman, Michael</creator><creator>Delgado, Anna Falk</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><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><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope><orcidid>https://orcid.org/0000-0003-4389-5089</orcidid><orcidid>https://orcid.org/0000-0002-0363-1284</orcidid><orcidid>https://orcid.org/0000-0002-5941-7412</orcidid><orcidid>https://orcid.org/0000-0002-0377-3506</orcidid><orcidid>https://orcid.org/0000-0002-9690-0286</orcidid></search><sort><creationdate>20241201</creationdate><title>Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial)</title><author>Ståhl, Fredrik ; Almqvist, Håkan ; Aspelin, Åsa ; Kolloch, Jens ; Ghalamkari, Odett ; Gontu, Vamsi ; Schäfer, Dirk ; van de Haar, Peter ; Engel, Klaus-Jürgen ; van Nijnatten, Fred ; Holmberg, Åke ; Mazya, Michael V. ; Söderman, Michael ; Delgado, Anna Falk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-284082d825afabe905bcbba98a9fe6624badc840fad741a716d1c077c46c1de73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Accuracy</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Cone-Beam Computed Tomography - methods</topic><topic>Female</topic><topic>Hemorrhage</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neurology</topic><topic>Neuroradiology</topic><topic>Neurosurgery</topic><topic>Original</topic><topic>Original Article</topic><topic>Prospective Studies</topic><topic>Radiography, Interventional - methods</topic><topic>Stroke</topic><topic>Stroke - diagnostic imaging</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ståhl, Fredrik</creatorcontrib><creatorcontrib>Almqvist, Håkan</creatorcontrib><creatorcontrib>Aspelin, Åsa</creatorcontrib><creatorcontrib>Kolloch, Jens</creatorcontrib><creatorcontrib>Ghalamkari, Odett</creatorcontrib><creatorcontrib>Gontu, Vamsi</creatorcontrib><creatorcontrib>Schäfer, Dirk</creatorcontrib><creatorcontrib>van de Haar, Peter</creatorcontrib><creatorcontrib>Engel, Klaus-Jürgen</creatorcontrib><creatorcontrib>van Nijnatten, Fred</creatorcontrib><creatorcontrib>Holmberg, Åke</creatorcontrib><creatorcontrib>Mazya, Michael V.</creatorcontrib><creatorcontrib>Söderman, Michael</creatorcontrib><creatorcontrib>Delgado, Anna Falk</creatorcontrib><collection>Springer Nature OA Free Journals</collection><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><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>Clinical neuroradiology (Munich)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ståhl, Fredrik</au><au>Almqvist, Håkan</au><au>Aspelin, Åsa</au><au>Kolloch, Jens</au><au>Ghalamkari, Odett</au><au>Gontu, Vamsi</au><au>Schäfer, Dirk</au><au>van de Haar, Peter</au><au>Engel, Klaus-Jürgen</au><au>van Nijnatten, Fred</au><au>Holmberg, Åke</au><au>Mazya, Michael V.</au><au>Söderman, Michael</au><au>Delgado, Anna Falk</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial)</atitle><jtitle>Clinical neuroradiology (Munich)</jtitle><stitle>Clin Neuroradiol</stitle><addtitle>Clin Neuroradiol</addtitle><date>2024-12-01</date><risdate>2024</risdate><volume>34</volume><issue>4</issue><spage>929</spage><epage>937</epage><pages>929-937</pages><issn>1869-1439</issn><issn>1869-1447</issn><eissn>1869-1447</eissn><abstract>Purpose
Cone-beam CT in the interventional suite could be an alternative to CT to shorten door-to-thrombectomy time. However, image quality in cone-beam CT is limited by artifacts and poor differentiation between gray and white matter. This study compared non-contrast brain dual-layer cone-beam CT in the interventional suite to reference standard CT in stroke patients.
Methods
A prospective single-center study enrolled consecutive participants with ischemic or hemorrhagic stroke. The hemorrhage detection accuracy, per-region ASPECTS accuracy and subjective image quality (Likert scales for gray-white matter differentiation, structure perception and artifacts) were assessed by three neuroradiologists blinded to clinical data on dual-layer cone-beam CT 75 keV monoenergetic images compared to CT. Objective image quality was assessed by region-of-interest metrics. Non-inferiority for hemorrhage detection and ASPECTS accuracy was determined by the exact binomial test with a one-sided lower performance boundary prospectively set to 80% (98.75% CI).
Results
27 participants were included (74 years ± 9; 19 female) in the hyperacute or acute stroke phase. One reader missed a small bleeding, but all hemorrhages were detected in the majority analysis (100% accuracy, CI lower boundary 86%,
p
= 0.002). ASPECTS majority analysis showed 90% accuracy (CI lower boundary 85%,
p
< 0.001). Sensitivity was 66% (individual readers 67%, 69%, and 76%), specificity was 97% (97%, 96%, 89%). Subjective and objective image quality were inferior to CT.
Conclusion
In a small single-center cohort, dual-layer cone-beam CT showed non-inferior hemorrhage detection and ASPECTS accuracy to CT. Despite inferior image quality, the technique may be useful for stroke evaluation in the interventional suite.
Trial Registration Number
NCT04571099 (clinicaltrials.gov). Prospectively registered 2020-09-04.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>39052054</pmid><doi>10.1007/s00062-024-01439-7</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-4389-5089</orcidid><orcidid>https://orcid.org/0000-0002-0363-1284</orcidid><orcidid>https://orcid.org/0000-0002-5941-7412</orcidid><orcidid>https://orcid.org/0000-0002-0377-3506</orcidid><orcidid>https://orcid.org/0000-0002-9690-0286</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1869-1439 |
| ispartof | Clinical neuroradiology (Munich), 2024-12, Vol.34 (4), p.929-937 |
| issn | 1869-1439 1869-1447 1869-1447 |
| language | eng |
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| source | MEDLINE; SWEPUB Freely available online; Springer Nature - Complete Springer Journals |
| subjects | Accuracy Aged Aged, 80 and over Cone-Beam Computed Tomography - methods Female Hemorrhage Humans Male Medicine Medicine & Public Health Middle Aged Neurology Neuroradiology Neurosurgery Original Original Article Prospective Studies Radiography, Interventional - methods Stroke Stroke - diagnostic imaging |
| title | Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial) |
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