AustralieFrV1, Main, Exploration, bibRecord, 004D14

Recommendations for imaging tumor response in neurofibromatosis clinical trials

Identifieur interne : 004D14 ( Main/Exploration ); précédent : 004D13; suivant : 004D15

Recommendations for imaging tumor response in neurofibromatosis clinical trials

Auteurs : Eva Dombi [États-Unis] ; Simone L. Ardern-Holmes [Australie] ; Dusica Babovic-Vuksanovic [Australie] ; Fred G. Barker [États-Unis] ; Steve Connor [Royaume-Uni] ; D. Gareth Evans [Royaume-Uni] ; Michael J. Fisher [États-Unis] ; Stephane Goutagny [France] ; Gordon J. Harris [États-Unis] ; Diego Jaramillo [États-Unis] ; Matthias A. Karajannis [États-Unis] ; Bruce R. Korf [États-Unis] ; Victor Mautner [Allemagne] ; Scott R. Plotkin [États-Unis] ; Tina Y. Poussaint [Royaume-Uni] ; Kent Robertson [États-Unis] ; Chie-Schin Shih [États-Unis] ; Brigitte C. Widemann [États-Unis]

Source :

Neurology [ 0028-3878 ] ; 2013.

RBID : Pascal:14-0014827

Descripteurs français

KwdFr :
- Diagnostic par imagerie (), Diagnostic par imagerie (normes), Essais cliniques comme sujet (), Essais cliniques comme sujet (normes), Humains, Microenvironnement tumoral, Neurinome de l'acoustique (), Neurinome de l'acoustique (diagnostic), Neurinome de l'acoustique (étiologie), Neurofibromatoses (), Neurofibromatoses (diagnostic), Neurofibrome plexiforme (), Neurofibrome plexiforme (diagnostic), Neurofibrome plexiforme (étiologie), Résultat thérapeutique.
MESH :
- diagnostic : Neurinome de l'acoustique, Neurofibromatoses, Neurofibrome plexiforme.
- normes : Diagnostic par imagerie, Essais cliniques comme sujet.
- étiologie : Neurinome de l'acoustique, Neurofibrome plexiforme.
Pascal (Inist)
- Diagnostic par imagerie, Essais cliniques comme sujet, Humains, Microenvironnement tumoral, Neurinome de l'acoustique, Neurofibromatose, Neurofibromatoses, Neurofibrome plexiforme, Pathologie du système nerveux, Recommandation, Essai clinique, Résultat thérapeutique.
Wicri :
- topic : Recommandation.

English descriptors

KwdEn :
- Clinical Trials as Topic (methods), Clinical Trials as Topic (standards), Clinical trial, Diagnostic Imaging (methods), Diagnostic Imaging (standards), Humans, Nervous system diseases, Neurofibroma, Plexiform (diagnosis), Neurofibroma, Plexiform (etiology), Neurofibroma, Plexiform (therapy), Neurofibromatoses (complications), Neurofibromatoses (diagnosis), Neurofibromatoses (therapy), Neurofibromatosis, Neuroma, Acoustic (diagnosis), Neuroma, Acoustic (etiology), Neuroma, Acoustic (therapy), Recommendation, Treatment Outcome, Tumor Microenvironment.
MESH :
- complications : Neurofibromatoses.
- diagnosis : Neurofibroma, Plexiform, Neurofibromatoses, Neuroma, Acoustic.
- etiology : Neurofibroma, Plexiform, Neuroma, Acoustic.
- methods : Clinical Trials as Topic, Diagnostic Imaging.
- standards : Clinical Trials as Topic, Diagnostic Imaging.
- therapy : Neurofibroma, Plexiform, Neurofibromatoses, Neuroma, Acoustic.
- Humans, Treatment Outcome, Tumor Microenvironment.

Abstract

Objective: Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Methods: Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. Results: MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. Conclusions: The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3908340

Affiliations:

Allemagne, Australie, France, Royaume-Uni, États-Unis
Angleterre, Grand Londres, Grand Manchester, Hambourg, Nouvelle-Galles du Sud
Hambourg, Londres, Manchester, Sydney

Le document en format XML

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<country>États-Unis</country>
<wicri:noRegion>Department of Radiology, The Children's Hospital of Philadelphia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Karajannis, Matthias A" sort="Karajannis, Matthias A" uniqKey="Karajannis M" first="Matthias A." last="Karajannis">Matthias A. Karajannis</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Division of Pediatric Hematology/Oncology and NYU Cancer Institute, NYU Langone Medical Center</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>New York, NY</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Korf, Bruce R" sort="Korf, Bruce R" uniqKey="Korf B" first="Bruce R." last="Korf">Bruce R. Korf</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Department of Genetics, University of Alabama at Birmingham</s1>
<s2>Birmingham, AL</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>Birmingham, AL</wicri:noRegion>
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<author><name sortKey="Mautner, Victor" sort="Mautner, Victor" uniqKey="Mautner V" first="Victor" last="Mautner">Victor Mautner</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Department of Neurology, University Medical Center Hamburg-Eppendorf</s1>
<s2>Hamburg</s2>
<s3>DEU</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
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</affiliation>
</author>
<author><name sortKey="Plotkin, Scott R" sort="Plotkin, Scott R" uniqKey="Plotkin S" first="Scott R." last="Plotkin">Scott R. Plotkin</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology and Cancer Center, Massachusetts General Hospital</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boston, MA</wicri:noRegion>
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<author><name sortKey="Poussaint, Tina Y" sort="Poussaint, Tina Y" uniqKey="Poussaint T" first="Tina Y." last="Poussaint">Tina Y. Poussaint</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Department of Radiology, Boston Children's Hospital</s1>
<s2>Boston, MA</s2>
<s3>GBR</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Boston, MA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Robertson, Kent" sort="Robertson, Kent" uniqKey="Robertson K" first="Kent" last="Robertson">Kent Robertson</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Pediatrics, Riley Hospital for Children</s1>
<s2>Indianapolis, IN</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>Indianapolis, IN</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Shih, Chie Schin" sort="Shih, Chie Schin" uniqKey="Shih C" first="Chie-Schin" last="Shih">Chie-Schin Shih</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Pediatrics, Riley Hospital for Children</s1>
<s2>Indianapolis, IN</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Indianapolis, IN</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Widemann, Brigitte C" sort="Widemann, Brigitte C" uniqKey="Widemann B" first="Brigitte C." last="Widemann">Brigitte C. Widemann</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Pediatric Oncology Branch, National Cancer Institute</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Bethesda, MD</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Neurology</title>
<title level="j" type="abbreviated">Neurology</title>
<idno type="ISSN">0028-3878</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Neurology</title>
<title level="j" type="abbreviated">Neurology</title>
<idno type="ISSN">0028-3878</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic (methods)</term>
<term>Clinical Trials as Topic (standards)</term>
<term>Clinical trial</term>
<term>Diagnostic Imaging (methods)</term>
<term>Diagnostic Imaging (standards)</term>
<term>Humans</term>
<term>Nervous system diseases</term>
<term>Neurofibroma, Plexiform (diagnosis)</term>
<term>Neurofibroma, Plexiform (etiology)</term>
<term>Neurofibroma, Plexiform (therapy)</term>
<term>Neurofibromatoses (complications)</term>
<term>Neurofibromatoses (diagnosis)</term>
<term>Neurofibromatoses (therapy)</term>
<term>Neurofibromatosis</term>
<term>Neuroma, Acoustic (diagnosis)</term>
<term>Neuroma, Acoustic (etiology)</term>
<term>Neuroma, Acoustic (therapy)</term>
<term>Recommendation</term>
<term>Treatment Outcome</term>
<term>Tumor Microenvironment</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Diagnostic par imagerie ()</term>
<term>Diagnostic par imagerie (normes)</term>
<term>Essais cliniques comme sujet ()</term>
<term>Essais cliniques comme sujet (normes)</term>
<term>Humains</term>
<term>Microenvironnement tumoral</term>
<term>Neurinome de l'acoustique ()</term>
<term>Neurinome de l'acoustique (diagnostic)</term>
<term>Neurinome de l'acoustique (étiologie)</term>
<term>Neurofibromatoses ()</term>
<term>Neurofibromatoses (diagnostic)</term>
<term>Neurofibrome plexiforme ()</term>
<term>Neurofibrome plexiforme (diagnostic)</term>
<term>Neurofibrome plexiforme (étiologie)</term>
<term>Résultat thérapeutique</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Neurofibromatoses</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Neurofibroma, Plexiform</term>
<term>Neurofibromatoses</term>
<term>Neuroma, Acoustic</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Neurinome de l'acoustique</term>
<term>Neurofibromatoses</term>
<term>Neurofibrome plexiforme</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Neurofibroma, Plexiform</term>
<term>Neuroma, Acoustic</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term>
<term>Diagnostic Imaging</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Diagnostic par imagerie</term>
<term>Essais cliniques comme sujet</term>
</keywords>
<keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Clinical Trials as Topic</term>
<term>Diagnostic Imaging</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Neurofibroma, Plexiform</term>
<term>Neurofibromatoses</term>
<term>Neuroma, Acoustic</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Neurinome de l'acoustique</term>
<term>Neurofibrome plexiforme</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Humans</term>
<term>Treatment Outcome</term>
<term>Tumor Microenvironment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Diagnostic par imagerie</term>
<term>Essais cliniques comme sujet</term>
<term>Humains</term>
<term>Microenvironnement tumoral</term>
<term>Neurinome de l'acoustique</term>
<term>Neurofibromatose</term>
<term>Neurofibromatoses</term>
<term>Neurofibrome plexiforme</term>
<term>Pathologie du   système nerveux</term>
<term>Recommandation</term>
<term>Essai clinique</term>
<term>Résultat thérapeutique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Recommandation</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Objective: Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Methods: Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. Results: MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. Conclusions: The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Grand Londres</li>
<li>Grand Manchester</li>
<li>Hambourg</li>
<li>Nouvelle-Galles du Sud</li>
</region>
<settlement><li>Hambourg</li>
<li>Londres</li>
<li>Manchester</li>
<li>Sydney</li>
</settlement>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="Dombi, Eva" sort="Dombi, Eva" uniqKey="Dombi E" first="Eva" last="Dombi">Eva Dombi</name>
</noRegion>
<name sortKey="Barker, Fred G" sort="Barker, Fred G" uniqKey="Barker F" first="Fred G." last="Barker">Fred G. Barker</name>
<name sortKey="Fisher, Michael J" sort="Fisher, Michael J" uniqKey="Fisher M" first="Michael J." last="Fisher">Michael J. Fisher</name>
<name sortKey="Fisher, Michael J" sort="Fisher, Michael J" uniqKey="Fisher M" first="Michael J." last="Fisher">Michael J. Fisher</name>
<name sortKey="Harris, Gordon J" sort="Harris, Gordon J" uniqKey="Harris G" first="Gordon J." last="Harris">Gordon J. Harris</name>
<name sortKey="Jaramillo, Diego" sort="Jaramillo, Diego" uniqKey="Jaramillo D" first="Diego" last="Jaramillo">Diego Jaramillo</name>
<name sortKey="Karajannis, Matthias A" sort="Karajannis, Matthias A" uniqKey="Karajannis M" first="Matthias A." last="Karajannis">Matthias A. Karajannis</name>
<name sortKey="Korf, Bruce R" sort="Korf, Bruce R" uniqKey="Korf B" first="Bruce R." last="Korf">Bruce R. Korf</name>
<name sortKey="Plotkin, Scott R" sort="Plotkin, Scott R" uniqKey="Plotkin S" first="Scott R." last="Plotkin">Scott R. Plotkin</name>
<name sortKey="Robertson, Kent" sort="Robertson, Kent" uniqKey="Robertson K" first="Kent" last="Robertson">Kent Robertson</name>
<name sortKey="Shih, Chie Schin" sort="Shih, Chie Schin" uniqKey="Shih C" first="Chie-Schin" last="Shih">Chie-Schin Shih</name>
<name sortKey="Widemann, Brigitte C" sort="Widemann, Brigitte C" uniqKey="Widemann B" first="Brigitte C." last="Widemann">Brigitte C. Widemann</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Ardern Holmes, Simone L" sort="Ardern Holmes, Simone L" uniqKey="Ardern Holmes S" first="Simone L." last="Ardern-Holmes">Simone L. Ardern-Holmes</name>
</region>
<name sortKey="Babovic Vuksanovic, Dusica" sort="Babovic Vuksanovic, Dusica" uniqKey="Babovic Vuksanovic D" first="Dusica" last="Babovic-Vuksanovic">Dusica Babovic-Vuksanovic</name>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Connor, Steve" sort="Connor, Steve" uniqKey="Connor S" first="Steve" last="Connor">Steve Connor</name>
</region>
<name sortKey="Evans, D Gareth" sort="Evans, D Gareth" uniqKey="Evans D" first="D. Gareth" last="Evans">D. Gareth Evans</name>
<name sortKey="Poussaint, Tina Y" sort="Poussaint, Tina Y" uniqKey="Poussaint T" first="Tina Y." last="Poussaint">Tina Y. Poussaint</name>
</country>
<country name="France"><noRegion><name sortKey="Goutagny, Stephane" sort="Goutagny, Stephane" uniqKey="Goutagny S" first="Stephane" last="Goutagny">Stephane Goutagny</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Hambourg"><name sortKey="Mautner, Victor" sort="Mautner, Victor" uniqKey="Mautner V" first="Victor" last="Mautner">Victor Mautner</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Recommendations for imaging tumor response in neurofibromatosis clinical trials

Recommendations for imaging tumor response in neurofibromatosis clinical trials

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