A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease
Objectives To assess the efficacy and safety of 99m Tc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD). Methods 99m Tc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Se...
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| Veröffentlicht in: | Annals of nuclear medicine 2020, Vol.34 (1), p.31-37 |
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| creator | Sun, Yu Liu, Congjin Chen, Zhengping Li, Biao Lv, Zhongwei Wang, Jian Lou, Jingjing Tang, Jie Wang, Yuankai Zhang, Guangming Liu, Xingdang |
| description | Objectives
To assess the efficacy and safety of
99m
Tc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD).
Methods
99m
Tc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT were analyzed according to Hoehn and Yahr scale (HYS). Based on HYS, the PD patients were divided into mild (HYS 1–2) and moderate (HYS 3–5) groups. The uptake ratios of striatum (ST) and cerebellum (CB) in contralateral, ipsilateral and bilateral striatum in different groups were calculated and analyzed. The safety was assessed.
Results
The sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT to discriminate PD patients from healthy subjects were 98.96% and 94.12% and it has perfect agreement with HYS (
κ
= 0.94,
p
|
| doi_str_mv | 10.1007/s12149-019-01412-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2308519298</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2308519298</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2212-1fbb952c850175029b90591b3f6debcb5c074e92ea6e764d8c579b4c5b72a8923</originalsourceid><addsrcrecordid>eNp9kcFu1DAQhi0EEkvhBThZ4sKhLvbEju3jaikUqVKrNpwt25nQlGyy2A7S3rj0IXg9noQsWwmJA4fRXL7_n3_0E_Ja8DPBuX6XBQhpGReHkQIYPCErYWrJallVT8mKWyGZFkY_Jy9yvuccjDKwIg9rurvzGSmc0mmHIxt8wOGUbueh9CziWDDRXOZ2T8tE8bsfZl-Qljuk2HV99HFP_djS7Dssezp11NptE1lzc_V-3TBBb6_PN81B22LBWOi1T1_7MU_jrx8_M237jMv1l-RZ54eMrx73Cfn84bzZXLDLq4-fNutLFgGWp0QXglUQjeJCKw42WK6sCFVXtxhiUJFriRbQ16hr2ZqotA0yqqDBGwvVCXl79N2l6duMubhtnyMOgx9xmrODihslLFizoG_-Qe-nOY1LuoWSFWitpF0oOFIxTTkn7Nwu9Vuf9k5wd2jGHZtxSzPuTzPukKI6ivICj18w_bX-j-o3LY-Plg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2343277549</pqid></control><display><type>article</type><title>A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease</title><source>Springer Online Journals Complete</source><creator>Sun, Yu ; Liu, Congjin ; Chen, Zhengping ; Li, Biao ; Lv, Zhongwei ; Wang, Jian ; Lou, Jingjing ; Tang, Jie ; Wang, Yuankai ; Zhang, Guangming ; Liu, Xingdang</creator><creatorcontrib>Sun, Yu ; Liu, Congjin ; Chen, Zhengping ; Li, Biao ; Lv, Zhongwei ; Wang, Jian ; Lou, Jingjing ; Tang, Jie ; Wang, Yuankai ; Zhang, Guangming ; Liu, Xingdang</creatorcontrib><description>Objectives
To assess the efficacy and safety of
99m
Tc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD).
Methods
99m
Tc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT were analyzed according to Hoehn and Yahr scale (HYS). Based on HYS, the PD patients were divided into mild (HYS 1–2) and moderate (HYS 3–5) groups. The uptake ratios of striatum (ST) and cerebellum (CB) in contralateral, ipsilateral and bilateral striatum in different groups were calculated and analyzed. The safety was assessed.
Results
The sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT to discriminate PD patients from healthy subjects were 98.96% and 94.12% and it has perfect agreement with HYS (
κ
= 0.94,
p
< 0.001). The sensitivity to diagnose mild and moderate PD was 43.42% and 95% separately. The uptake ratio in PD patients was significantly lower than that in healthy controls (1.37 ± 0.13 vs 1.68 ± 0.18,
p
< 0.001). And the uptake ratio in contralateral side was markedly reduced in unilateral PD patients as compared with the ipsilateral side (1.50 ± 0.20 vs 1.46 ± 0.21,
p
< 0.001). The striatal uptakes in affected striatum and bilateral striatum were reduced with increasing disease severity between healthy control versus mild stage versus moderate stage in the affected striatum and bilateral striatum in PD patients. No serious adverse events or death was observed after injecting
99m
Tc-TRODAT-1.
Conclusion
We demonstrated that
99m
Tc-TRODAT-1 was a safety radiotracer which can be used in clinic to diagnose PD using SPECT.</description><identifier>ISSN: 0914-7187</identifier><identifier>EISSN: 1864-6433</identifier><identifier>DOI: 10.1007/s12149-019-01412-2</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Cerebellum ; Disease control ; Evaluation ; Imaging ; Medical diagnosis ; Medicine ; Medicine & Public Health ; Movement disorders ; Neostriatum ; Neurodegenerative diseases ; Nuclear Medicine ; Original Article ; Parkinson's disease ; Radioactive tracers ; Radiology ; Safety ; Sensitivity analysis ; Single photon emission computed tomography</subject><ispartof>Annals of nuclear medicine, 2020, Vol.34 (1), p.31-37</ispartof><rights>The Japanese Society of Nuclear Medicine 2019</rights><rights>2019© The Japanese Society of Nuclear Medicine 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2212-1fbb952c850175029b90591b3f6debcb5c074e92ea6e764d8c579b4c5b72a8923</citedby><cites>FETCH-LOGICAL-c2212-1fbb952c850175029b90591b3f6debcb5c074e92ea6e764d8c579b4c5b72a8923</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12149-019-01412-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12149-019-01412-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>Sun, Yu</creatorcontrib><creatorcontrib>Liu, Congjin</creatorcontrib><creatorcontrib>Chen, Zhengping</creatorcontrib><creatorcontrib>Li, Biao</creatorcontrib><creatorcontrib>Lv, Zhongwei</creatorcontrib><creatorcontrib>Wang, Jian</creatorcontrib><creatorcontrib>Lou, Jingjing</creatorcontrib><creatorcontrib>Tang, Jie</creatorcontrib><creatorcontrib>Wang, Yuankai</creatorcontrib><creatorcontrib>Zhang, Guangming</creatorcontrib><creatorcontrib>Liu, Xingdang</creatorcontrib><title>A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease</title><title>Annals of nuclear medicine</title><addtitle>Ann Nucl Med</addtitle><description>Objectives
To assess the efficacy and safety of
99m
Tc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD).
Methods
99m
Tc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT were analyzed according to Hoehn and Yahr scale (HYS). Based on HYS, the PD patients were divided into mild (HYS 1–2) and moderate (HYS 3–5) groups. The uptake ratios of striatum (ST) and cerebellum (CB) in contralateral, ipsilateral and bilateral striatum in different groups were calculated and analyzed. The safety was assessed.
Results
The sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT to discriminate PD patients from healthy subjects were 98.96% and 94.12% and it has perfect agreement with HYS (
κ
= 0.94,
p
< 0.001). The sensitivity to diagnose mild and moderate PD was 43.42% and 95% separately. The uptake ratio in PD patients was significantly lower than that in healthy controls (1.37 ± 0.13 vs 1.68 ± 0.18,
p
< 0.001). And the uptake ratio in contralateral side was markedly reduced in unilateral PD patients as compared with the ipsilateral side (1.50 ± 0.20 vs 1.46 ± 0.21,
p
< 0.001). The striatal uptakes in affected striatum and bilateral striatum were reduced with increasing disease severity between healthy control versus mild stage versus moderate stage in the affected striatum and bilateral striatum in PD patients. No serious adverse events or death was observed after injecting
99m
Tc-TRODAT-1.
Conclusion
We demonstrated that
99m
Tc-TRODAT-1 was a safety radiotracer which can be used in clinic to diagnose PD using SPECT.</description><subject>Cerebellum</subject><subject>Disease control</subject><subject>Evaluation</subject><subject>Imaging</subject><subject>Medical diagnosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Movement disorders</subject><subject>Neostriatum</subject><subject>Neurodegenerative diseases</subject><subject>Nuclear Medicine</subject><subject>Original Article</subject><subject>Parkinson's disease</subject><subject>Radioactive tracers</subject><subject>Radiology</subject><subject>Safety</subject><subject>Sensitivity analysis</subject><subject>Single photon emission computed tomography</subject><issn>0914-7187</issn><issn>1864-6433</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kcFu1DAQhi0EEkvhBThZ4sKhLvbEju3jaikUqVKrNpwt25nQlGyy2A7S3rj0IXg9noQsWwmJA4fRXL7_n3_0E_Ja8DPBuX6XBQhpGReHkQIYPCErYWrJallVT8mKWyGZFkY_Jy9yvuccjDKwIg9rurvzGSmc0mmHIxt8wOGUbueh9CziWDDRXOZ2T8tE8bsfZl-Qljuk2HV99HFP_djS7Dssezp11NptE1lzc_V-3TBBb6_PN81B22LBWOi1T1_7MU_jrx8_M237jMv1l-RZ54eMrx73Cfn84bzZXLDLq4-fNutLFgGWp0QXglUQjeJCKw42WK6sCFVXtxhiUJFriRbQ16hr2ZqotA0yqqDBGwvVCXl79N2l6duMubhtnyMOgx9xmrODihslLFizoG_-Qe-nOY1LuoWSFWitpF0oOFIxTTkn7Nwu9Vuf9k5wd2jGHZtxSzPuTzPukKI6ivICj18w_bX-j-o3LY-Plg</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Sun, Yu</creator><creator>Liu, Congjin</creator><creator>Chen, Zhengping</creator><creator>Li, Biao</creator><creator>Lv, Zhongwei</creator><creator>Wang, Jian</creator><creator>Lou, Jingjing</creator><creator>Tang, Jie</creator><creator>Wang, Yuankai</creator><creator>Zhang, Guangming</creator><creator>Liu, Xingdang</creator><general>Springer Singapore</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7TK</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>2020</creationdate><title>A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease</title><author>Sun, Yu ; Liu, Congjin ; Chen, Zhengping ; Li, Biao ; Lv, Zhongwei ; Wang, Jian ; Lou, Jingjing ; Tang, Jie ; Wang, Yuankai ; Zhang, Guangming ; Liu, Xingdang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2212-1fbb952c850175029b90591b3f6debcb5c074e92ea6e764d8c579b4c5b72a8923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Cerebellum</topic><topic>Disease control</topic><topic>Evaluation</topic><topic>Imaging</topic><topic>Medical diagnosis</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Movement disorders</topic><topic>Neostriatum</topic><topic>Neurodegenerative diseases</topic><topic>Nuclear Medicine</topic><topic>Original Article</topic><topic>Parkinson's disease</topic><topic>Radioactive tracers</topic><topic>Radiology</topic><topic>Safety</topic><topic>Sensitivity analysis</topic><topic>Single photon emission computed tomography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sun, Yu</creatorcontrib><creatorcontrib>Liu, Congjin</creatorcontrib><creatorcontrib>Chen, Zhengping</creatorcontrib><creatorcontrib>Li, Biao</creatorcontrib><creatorcontrib>Lv, Zhongwei</creatorcontrib><creatorcontrib>Wang, Jian</creatorcontrib><creatorcontrib>Lou, Jingjing</creatorcontrib><creatorcontrib>Tang, Jie</creatorcontrib><creatorcontrib>Wang, Yuankai</creatorcontrib><creatorcontrib>Zhang, Guangming</creatorcontrib><creatorcontrib>Liu, Xingdang</creatorcontrib><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of nuclear medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sun, Yu</au><au>Liu, Congjin</au><au>Chen, Zhengping</au><au>Li, Biao</au><au>Lv, Zhongwei</au><au>Wang, Jian</au><au>Lou, Jingjing</au><au>Tang, Jie</au><au>Wang, Yuankai</au><au>Zhang, Guangming</au><au>Liu, Xingdang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease</atitle><jtitle>Annals of nuclear medicine</jtitle><stitle>Ann Nucl Med</stitle><date>2020</date><risdate>2020</risdate><volume>34</volume><issue>1</issue><spage>31</spage><epage>37</epage><pages>31-37</pages><issn>0914-7187</issn><eissn>1864-6433</eissn><abstract>Objectives
To assess the efficacy and safety of
99m
Tc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD).
Methods
99m
Tc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT were analyzed according to Hoehn and Yahr scale (HYS). Based on HYS, the PD patients were divided into mild (HYS 1–2) and moderate (HYS 3–5) groups. The uptake ratios of striatum (ST) and cerebellum (CB) in contralateral, ipsilateral and bilateral striatum in different groups were calculated and analyzed. The safety was assessed.
Results
The sensitivity and specificity of
99m
Tc-TRODAT-1 SPECT to discriminate PD patients from healthy subjects were 98.96% and 94.12% and it has perfect agreement with HYS (
κ
= 0.94,
p
< 0.001). The sensitivity to diagnose mild and moderate PD was 43.42% and 95% separately. The uptake ratio in PD patients was significantly lower than that in healthy controls (1.37 ± 0.13 vs 1.68 ± 0.18,
p
< 0.001). And the uptake ratio in contralateral side was markedly reduced in unilateral PD patients as compared with the ipsilateral side (1.50 ± 0.20 vs 1.46 ± 0.21,
p
< 0.001). The striatal uptakes in affected striatum and bilateral striatum were reduced with increasing disease severity between healthy control versus mild stage versus moderate stage in the affected striatum and bilateral striatum in PD patients. No serious adverse events or death was observed after injecting
99m
Tc-TRODAT-1.
Conclusion
We demonstrated that
99m
Tc-TRODAT-1 was a safety radiotracer which can be used in clinic to diagnose PD using SPECT.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><doi>10.1007/s12149-019-01412-2</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0914-7187 |
| ispartof | Annals of nuclear medicine, 2020, Vol.34 (1), p.31-37 |
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| language | eng |
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| source | Springer Online Journals Complete |
| subjects | Cerebellum Disease control Evaluation Imaging Medical diagnosis Medicine Medicine & Public Health Movement disorders Neostriatum Neurodegenerative diseases Nuclear Medicine Original Article Parkinson's disease Radioactive tracers Radiology Safety Sensitivity analysis Single photon emission computed tomography |
| title | A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease |
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