Multicenter Clinical Trials Using 18F-FDG PET to Measure Early Response to Oncologic Therapy: Effects of Injection-to-Acquisition Time Variability on Required Sample Size
Uptake time (interval between tracer injection and image acquisition) affects the SUV measured for tumors in (18)F-FDG PET images. With dissimilar uptake times, changes in tumor SUVs will be under- or overestimated. This study examined the influence of uptake time on tumor response assessment using...
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| Veröffentlicht in: | The Journal of nuclear medicine (1978) 2016-02, Vol.57 (2), p.226-230 |
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| container_title | The Journal of nuclear medicine (1978) |
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| creator | Kurland, Brenda F Muzi, Mark Peterson, Lanell M Doot, Robert K Wangerin, Kristen A Mankoff, David A Linden, Hannah M Kinahan, Paul E |
| description | Uptake time (interval between tracer injection and image acquisition) affects the SUV measured for tumors in (18)F-FDG PET images. With dissimilar uptake times, changes in tumor SUVs will be under- or overestimated. This study examined the influence of uptake time on tumor response assessment using a virtual clinical trials approach.
Tumor kinetic parameters were estimated from dynamic (18)F-FDG PET scans of breast cancer patients and used to simulate time-activity curves for 45-120 min after injection. Five-minute uptake time frames followed 4 scenarios: the first was a standardized static uptake time (the SUV from 60 to 65 min was selected for all scans), the second was uptake times sampled from an academic PET facility with strict adherence to standardization protocols, the third was a distribution similar to scenario 2 but with greater deviation from standards, and the fourth was a mixture of hurried scans (45- to 65-min start of image acquisition) and frequent delays (58- to 115-min uptake time). The proportion of out-of-range scans (70 min, or >15-min difference between paired scans) was 0%, 20%, 44%, and 64% for scenarios 1, 2, 3, and 4, respectively. A published SUV correction based on local linearity of uptake-time dependence was applied in a separate analysis. Influence of uptake-time variation was assessed as sensitivity for detecting response (probability of observing a change of ≥30% decrease in (18)F-FDG PET SUV given a true decrease of 40%) and specificity (probability of observing an absolute change of |
| doi_str_mv | 10.2967/jnumed.115.162289 |
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Tumor kinetic parameters were estimated from dynamic (18)F-FDG PET scans of breast cancer patients and used to simulate time-activity curves for 45-120 min after injection. Five-minute uptake time frames followed 4 scenarios: the first was a standardized static uptake time (the SUV from 60 to 65 min was selected for all scans), the second was uptake times sampled from an academic PET facility with strict adherence to standardization protocols, the third was a distribution similar to scenario 2 but with greater deviation from standards, and the fourth was a mixture of hurried scans (45- to 65-min start of image acquisition) and frequent delays (58- to 115-min uptake time). The proportion of out-of-range scans (<50 or >70 min, or >15-min difference between paired scans) was 0%, 20%, 44%, and 64% for scenarios 1, 2, 3, and 4, respectively. A published SUV correction based on local linearity of uptake-time dependence was applied in a separate analysis. Influence of uptake-time variation was assessed as sensitivity for detecting response (probability of observing a change of ≥30% decrease in (18)F-FDG PET SUV given a true decrease of 40%) and specificity (probability of observing an absolute change of <30% given no true change).
Sensitivity was 96% for scenario 1, and ranged from 73% for scenario 4 (95% confidence interval, 70%-76%) to 92% (90%-93%) for scenario 2. Specificity for all scenarios was at least 91%. Single-arm phase II trials required an 8%-115% greater sample size for scenarios 2-4 than for scenario 1. If uptake time is known, SUV correction methods may raise sensitivity to 87%-95% and reduce the sample size increase to less than 27%.
Uptake-time deviations from standardized protocols occur frequently, potentially decreasing the performance of (18)F-FDG PET response biomarkers. Correcting SUV for uptake time improves sensitivity, but algorithm refinement is needed. Stricter uptake-time control and effective correction algorithms could improve power and decrease costs for clinical trials using (18)F-FDG PET endpoints.</description><identifier>EISSN: 1535-5667</identifier><identifier>DOI: 10.2967/jnumed.115.162289</identifier><identifier>PMID: 26493206</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Algorithms ; Biomarkers ; Breast Neoplasms - diagnostic imaging ; Breast Neoplasms - metabolism ; Breast Neoplasms - therapy ; Female ; Fluorodeoxyglucose F18 - pharmacokinetics ; Humans ; Middle Aged ; Positron-Emission Tomography - methods ; Prospective Studies ; Radiopharmaceuticals - pharmacokinetics ; Reference Standards ; Reproducibility of Results ; Sample Size</subject><ispartof>The Journal of nuclear medicine (1978), 2016-02, Vol.57 (2), p.226-230</ispartof><rights>2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26493206$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kurland, Brenda F</creatorcontrib><creatorcontrib>Muzi, Mark</creatorcontrib><creatorcontrib>Peterson, Lanell M</creatorcontrib><creatorcontrib>Doot, Robert K</creatorcontrib><creatorcontrib>Wangerin, Kristen A</creatorcontrib><creatorcontrib>Mankoff, David A</creatorcontrib><creatorcontrib>Linden, Hannah M</creatorcontrib><creatorcontrib>Kinahan, Paul E</creatorcontrib><title>Multicenter Clinical Trials Using 18F-FDG PET to Measure Early Response to Oncologic Therapy: Effects of Injection-to-Acquisition Time Variability on Required Sample Size</title><title>The Journal of nuclear medicine (1978)</title><addtitle>J Nucl Med</addtitle><description>Uptake time (interval between tracer injection and image acquisition) affects the SUV measured for tumors in (18)F-FDG PET images. With dissimilar uptake times, changes in tumor SUVs will be under- or overestimated. This study examined the influence of uptake time on tumor response assessment using a virtual clinical trials approach.
Tumor kinetic parameters were estimated from dynamic (18)F-FDG PET scans of breast cancer patients and used to simulate time-activity curves for 45-120 min after injection. Five-minute uptake time frames followed 4 scenarios: the first was a standardized static uptake time (the SUV from 60 to 65 min was selected for all scans), the second was uptake times sampled from an academic PET facility with strict adherence to standardization protocols, the third was a distribution similar to scenario 2 but with greater deviation from standards, and the fourth was a mixture of hurried scans (45- to 65-min start of image acquisition) and frequent delays (58- to 115-min uptake time). The proportion of out-of-range scans (<50 or >70 min, or >15-min difference between paired scans) was 0%, 20%, 44%, and 64% for scenarios 1, 2, 3, and 4, respectively. A published SUV correction based on local linearity of uptake-time dependence was applied in a separate analysis. Influence of uptake-time variation was assessed as sensitivity for detecting response (probability of observing a change of ≥30% decrease in (18)F-FDG PET SUV given a true decrease of 40%) and specificity (probability of observing an absolute change of <30% given no true change).
Sensitivity was 96% for scenario 1, and ranged from 73% for scenario 4 (95% confidence interval, 70%-76%) to 92% (90%-93%) for scenario 2. Specificity for all scenarios was at least 91%. Single-arm phase II trials required an 8%-115% greater sample size for scenarios 2-4 than for scenario 1. If uptake time is known, SUV correction methods may raise sensitivity to 87%-95% and reduce the sample size increase to less than 27%.
Uptake-time deviations from standardized protocols occur frequently, potentially decreasing the performance of (18)F-FDG PET response biomarkers. Correcting SUV for uptake time improves sensitivity, but algorithm refinement is needed. Stricter uptake-time control and effective correction algorithms could improve power and decrease costs for clinical trials using (18)F-FDG PET endpoints.</description><subject>Aged</subject><subject>Algorithms</subject><subject>Biomarkers</subject><subject>Breast Neoplasms - diagnostic imaging</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - therapy</subject><subject>Female</subject><subject>Fluorodeoxyglucose F18 - pharmacokinetics</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Positron-Emission Tomography - methods</subject><subject>Prospective Studies</subject><subject>Radiopharmaceuticals - pharmacokinetics</subject><subject>Reference Standards</subject><subject>Reproducibility of Results</subject><subject>Sample Size</subject><issn>1535-5667</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1UM1O3DAYtJBQ-WkfoBf0HblkazuxE_eGll2KBKKCtNeV7XyhXjl2sJPD9pF4SoJKT9_PjGZGQ8hXRldcyfrbPswDdivGxIpJzht1RE6ZKEUhpKxPyFnOe0qpbJrmEznhslIlp_KUvN7PfnIWw4QJ1t4FZ7WHNjntM_zKLjwDa7bF9voGfm5amCLco85zQtjo5A_wiHmMIeM78hBs9PHZWWj_YNLj4Tts-h7tlCH2cBv2y-piKKZYXNmX2WX3fkLrBoTferE0zrvpAMvvERc8YQdPehg9wpP7i5_Jcb-kwi8f85y02027_lHcPdzcrq_uilEpVaAQtDNCCamFkaVRtLRVqU3DuUJJ-042RjNlJWsqxrqac8OrqmLcdIwxLctzcvlPdkzxZcY87QaXLXqvA8Y571gteVnVnPKFevFBnc1S_m5MbtDpsPtfb_kG3jB8iQ</recordid><startdate>201602</startdate><enddate>201602</enddate><creator>Kurland, Brenda F</creator><creator>Muzi, Mark</creator><creator>Peterson, Lanell M</creator><creator>Doot, Robert K</creator><creator>Wangerin, Kristen A</creator><creator>Mankoff, David A</creator><creator>Linden, Hannah M</creator><creator>Kinahan, Paul E</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201602</creationdate><title>Multicenter Clinical Trials Using 18F-FDG PET to Measure Early Response to Oncologic Therapy: Effects of Injection-to-Acquisition Time Variability on Required Sample Size</title><author>Kurland, Brenda F ; Muzi, Mark ; Peterson, Lanell M ; Doot, Robert K ; Wangerin, Kristen A ; Mankoff, David A ; Linden, Hannah M ; Kinahan, Paul E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p999-e550db5956a5b63b903c43ab8229e60fd68ba19c618411d722b244412bd111a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Algorithms</topic><topic>Biomarkers</topic><topic>Breast Neoplasms - diagnostic imaging</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - therapy</topic><topic>Female</topic><topic>Fluorodeoxyglucose F18 - pharmacokinetics</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Positron-Emission Tomography - methods</topic><topic>Prospective Studies</topic><topic>Radiopharmaceuticals - pharmacokinetics</topic><topic>Reference Standards</topic><topic>Reproducibility of Results</topic><topic>Sample Size</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kurland, Brenda F</creatorcontrib><creatorcontrib>Muzi, Mark</creatorcontrib><creatorcontrib>Peterson, Lanell M</creatorcontrib><creatorcontrib>Doot, Robert K</creatorcontrib><creatorcontrib>Wangerin, Kristen A</creatorcontrib><creatorcontrib>Mankoff, David A</creatorcontrib><creatorcontrib>Linden, Hannah M</creatorcontrib><creatorcontrib>Kinahan, Paul E</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of nuclear medicine (1978)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kurland, Brenda F</au><au>Muzi, Mark</au><au>Peterson, Lanell M</au><au>Doot, Robert K</au><au>Wangerin, Kristen A</au><au>Mankoff, David A</au><au>Linden, Hannah M</au><au>Kinahan, Paul E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter Clinical Trials Using 18F-FDG PET to Measure Early Response to Oncologic Therapy: Effects of Injection-to-Acquisition Time Variability on Required Sample Size</atitle><jtitle>The Journal of nuclear medicine (1978)</jtitle><addtitle>J Nucl Med</addtitle><date>2016-02</date><risdate>2016</risdate><volume>57</volume><issue>2</issue><spage>226</spage><epage>230</epage><pages>226-230</pages><eissn>1535-5667</eissn><abstract>Uptake time (interval between tracer injection and image acquisition) affects the SUV measured for tumors in (18)F-FDG PET images. With dissimilar uptake times, changes in tumor SUVs will be under- or overestimated. This study examined the influence of uptake time on tumor response assessment using a virtual clinical trials approach.
Tumor kinetic parameters were estimated from dynamic (18)F-FDG PET scans of breast cancer patients and used to simulate time-activity curves for 45-120 min after injection. Five-minute uptake time frames followed 4 scenarios: the first was a standardized static uptake time (the SUV from 60 to 65 min was selected for all scans), the second was uptake times sampled from an academic PET facility with strict adherence to standardization protocols, the third was a distribution similar to scenario 2 but with greater deviation from standards, and the fourth was a mixture of hurried scans (45- to 65-min start of image acquisition) and frequent delays (58- to 115-min uptake time). The proportion of out-of-range scans (<50 or >70 min, or >15-min difference between paired scans) was 0%, 20%, 44%, and 64% for scenarios 1, 2, 3, and 4, respectively. A published SUV correction based on local linearity of uptake-time dependence was applied in a separate analysis. Influence of uptake-time variation was assessed as sensitivity for detecting response (probability of observing a change of ≥30% decrease in (18)F-FDG PET SUV given a true decrease of 40%) and specificity (probability of observing an absolute change of <30% given no true change).
Sensitivity was 96% for scenario 1, and ranged from 73% for scenario 4 (95% confidence interval, 70%-76%) to 92% (90%-93%) for scenario 2. Specificity for all scenarios was at least 91%. Single-arm phase II trials required an 8%-115% greater sample size for scenarios 2-4 than for scenario 1. If uptake time is known, SUV correction methods may raise sensitivity to 87%-95% and reduce the sample size increase to less than 27%.
Uptake-time deviations from standardized protocols occur frequently, potentially decreasing the performance of (18)F-FDG PET response biomarkers. Correcting SUV for uptake time improves sensitivity, but algorithm refinement is needed. Stricter uptake-time control and effective correction algorithms could improve power and decrease costs for clinical trials using (18)F-FDG PET endpoints.</abstract><cop>United States</cop><pmid>26493206</pmid><doi>10.2967/jnumed.115.162289</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Algorithms Biomarkers Breast Neoplasms - diagnostic imaging Breast Neoplasms - metabolism Breast Neoplasms - therapy Female Fluorodeoxyglucose F18 - pharmacokinetics Humans Middle Aged Positron-Emission Tomography - methods Prospective Studies Radiopharmaceuticals - pharmacokinetics Reference Standards Reproducibility of Results Sample Size |
| title | Multicenter Clinical Trials Using 18F-FDG PET to Measure Early Response to Oncologic Therapy: Effects of Injection-to-Acquisition Time Variability on Required Sample Size |
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