Phase I trial of intraoperative detection of tumor margins in patients with HER2-positive carcinoma of the breast following administration of 111In-DTPA-trastuzumab Fab fragments.
Identifieur interne : 000479 ( Main/Exploration ); précédent : 000478; suivant : 000480Phase I trial of intraoperative detection of tumor margins in patients with HER2-positive carcinoma of the breast following administration of 111In-DTPA-trastuzumab Fab fragments.
Auteurs : RBID : pubmed:23618841English descriptors
- KwdEn :
- Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (chemistry), Antibodies, Monoclonal, Humanized (diagnostic use), Antibodies, Monoclonal, Humanized (pharmacokinetics), Breast Neoplasms (diagnosis), Breast Neoplasms (pathology), Breast Neoplasms (radionuclide imaging), Breast Neoplasms (surgery), Feasibility Studies, Female, Humans, Immunoglobulin Fab Fragments (chemistry), Indium Radioisotopes (diagnostic use), Intraoperative Period, Middle Aged, Pentetic Acid (chemistry), Radiometry, Radiopharmaceuticals (administration & dosage), Radiopharmaceuticals (chemistry), Radiopharmaceuticals (diagnostic use), Radiopharmaceuticals (pharmacokinetics), Receptor, erbB-2 (metabolism), Safety, Tomography, Emission-Computed, Single-Photon.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Radiopharmaceuticals.
- chemical , chemistry : Antibodies, Monoclonal, Humanized, Immunoglobulin Fab Fragments, Pentetic Acid, Radiopharmaceuticals.
- chemical , diagnostic use : Antibodies, Monoclonal, Humanized, Indium Radioisotopes, Radiopharmaceuticals.
- chemical , metabolism : Receptor, erbB-2.
- chemical , pharmacokinetics : Antibodies, Monoclonal, Humanized, Radiopharmaceuticals.
- diagnosis : Breast Neoplasms.
- pathology : Breast Neoplasms.
- radionuclide imaging : Breast Neoplasms.
- surgery : Breast Neoplasms.
- Feasibility Studies, Female, Humans, Intraoperative Period, Middle Aged, Radiometry, Safety, Tomography, Emission-Computed, Single-Photon.
Abstract
Our aim was to conduct a Phase I clinical trial to determine the feasibility of intraoperative detection of tumor margins in HER2 positive breast carcinoma using a hand-held γ-probe following administration of (111)In-DTPA-trastuzumab Fab fragments. Accurate delineation of tumor margins is important for preventing local recurrence.
DOI: 10.1016/j.nucmedbio.2013.03.005
PubMed: 23618841
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase I trial of intraoperative detection of tumor margins in patients with HER2-positive carcinoma of the breast following administration of 111In-DTPA-trastuzumab Fab fragments.</title><author><name sortKey="Holloway, Claire M B" uniqKey="Holloway C">Claire M B Holloway</name><affiliation><nlm:affiliation>Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada M4N 3M5. Claire.Holloway@sunnybrook.ca</nlm:affiliation><country wicri:rule="url">Canada</country></affiliation></author><author><name sortKey="Scollard, Deborah A" uniqKey="Scollard D">Deborah A Scollard</name></author><author><name sortKey="Caldwell, Curtis B" uniqKey="Caldwell C">Curtis B Caldwell</name></author><author><name sortKey="Ehrlich, Lisa" uniqKey="Ehrlich L">Lisa Ehrlich</name></author><author><name sortKey="Kahn, Harriette J" uniqKey="Kahn H">Harriette J Kahn</name></author><author><name sortKey="Reilly, Raymond M" uniqKey="Reilly R">Raymond M Reilly</name></author></titleStmt><publicationStmt><date when="2013">2013</date><idno type="doi">10.1016/j.nucmedbio.2013.03.005</idno><idno type="RBID">pubmed:23618841</idno><idno type="pmid">23618841</idno><idno type="wicri:Area/Main/Corpus">000655</idno><idno type="wicri:Area/Main/Curation">000655</idno><idno type="wicri:Area/Main/Exploration">000479</idno></publicationStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (chemistry)</term><term>Antibodies, Monoclonal, Humanized (diagnostic use)</term><term>Antibodies, Monoclonal, Humanized (pharmacokinetics)</term><term>Breast Neoplasms (diagnosis)</term><term>Breast Neoplasms (pathology)</term><term>Breast Neoplasms (radionuclide imaging)</term><term>Breast Neoplasms (surgery)</term><term>Feasibility Studies</term><term>Female</term><term>Humans</term><term>Immunoglobulin Fab Fragments (chemistry)</term><term>Indium Radioisotopes (diagnostic use)</term><term>Intraoperative Period</term><term>Middle Aged</term><term>Pentetic Acid (chemistry)</term><term>Radiometry</term><term>Radiopharmaceuticals (administration & dosage)</term><term>Radiopharmaceuticals (chemistry)</term><term>Radiopharmaceuticals (diagnostic use)</term><term>Radiopharmaceuticals (pharmacokinetics)</term><term>Receptor, erbB-2 (metabolism)</term><term>Safety</term><term>Tomography, Emission-Computed, Single-Photon</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Immunoglobulin Fab Fragments</term><term>Pentetic Acid</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" type="chemical" qualifier="diagnostic use" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Indium Radioisotopes</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Receptor, erbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="radionuclide imaging" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Feasibility Studies</term><term>Female</term><term>Humans</term><term>Intraoperative Period</term><term>Middle Aged</term><term>Radiometry</term><term>Safety</term><term>Tomography, Emission-Computed, Single-Photon</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Our aim was to conduct a Phase I clinical trial to determine the feasibility of intraoperative detection of tumor margins in HER2 positive breast carcinoma using a hand-held γ-probe following administration of (111)In-DTPA-trastuzumab Fab fragments. Accurate delineation of tumor margins is important for preventing local recurrence.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">23618841</PMID><DateCreated><Year>2013</Year><Month>05</Month><Day>27</Day></DateCreated><DateCompleted><Year>2014</Year><Month>01</Month><Day>10</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1872-9614</ISSN><JournalIssue CitedMedium="Internet"><Volume>40</Volume><Issue>5</Issue><PubDate><Year>2013</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Nuclear medicine and biology</Title><ISOAbbreviation>Nucl. Med. Biol.</ISOAbbreviation></Journal><ArticleTitle>Phase I trial of intraoperative detection of tumor margins in patients with HER2-positive carcinoma of the breast following administration of 111In-DTPA-trastuzumab Fab fragments.</ArticleTitle><Pagination><MedlinePgn>630-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.nucmedbio.2013.03.005</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0969-8051(13)00053-X</ELocationID><Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">Our aim was to conduct a Phase I clinical trial to determine the feasibility of intraoperative detection of tumor margins in HER2 positive breast carcinoma using a hand-held γ-probe following administration of (111)In-DTPA-trastuzumab Fab fragments. Accurate delineation of tumor margins is important for preventing local recurrence.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Six patients with HER2-positive in situ or invasive ductal carcinoma were administered 74MBq (0.5mg) of (111)In-DTPA-trastuzumab Fab fragments and counts in the tumor, surgical cavity wall and en face margins were measured intraoperatively at 72h post-injection using the Navigator or C-Trak γ-probes. Margins were evaluated histologically. Quantitative whole body planar imaging was performed to estimate radiation absorbed doses using OLINDA/EXM software. SPECT imaging of the thorax was performed to evaluate tumor uptake. The pharmacokinetics of elimination from the blood and plasma were determined over 72h.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">There were no acute adverse reactions from (111)In-DTPA-trastuzumab Fab fragments and no changes in hematological or biochemical indices were found over a 3month period. (111)In-DTPA-trastuzumab Fab fragments exhibited a biphasic elimination from the blood and plasma with t1/2α=11.9h and 7.5h, respectively, and t1/2β=26.6 and 20.7h, respectively. The radiopharmaceutical accumulated in the liver, spleen and kidneys. SPECT imaging did not reveal tumor in any patient. The mean effective dose was 0.146mSv/MBq (10.8mSv for 74MBq). Counts in excised tumors were low but were higher than in margins. Margins in two patients harboured tumor but this was not correlated with counts obtained using the γ-probes. Surgical cavity counts were high and likely due to detection of γ-photons outside the surgical field.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">We conclude that it was not feasible, at least at the administered amount of radioactivity used in this study, to reliably detect the margins of disease in patients with in situ or invasive ductal carcinoma intraoperatively using a hand-held γ-probe and (111)In-DTPA-trastuzumab Fab fragments due to low uptake in the tumor and involved margins.</AbstractText><CopyrightInformation>Copyright © 2013 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Holloway</LastName><ForeName>Claire M B</ForeName><Initials>CM</Initials><Affiliation>Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada M4N 3M5. Claire.Holloway@sunnybrook.ca</Affiliation></Author><Author ValidYN="Y"><LastName>Scollard</LastName><ForeName>Deborah A</ForeName><Initials>DA</Initials></Author><Author ValidYN="Y"><LastName>Caldwell</LastName><ForeName>Curtis B</ForeName><Initials>CB</Initials></Author><Author ValidYN="Y"><LastName>Ehrlich</LastName><ForeName>Lisa</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Kahn</LastName><ForeName>Harriette J</ForeName><Initials>HJ</Initials></Author><Author ValidYN="Y"><LastName>Reilly</LastName><ForeName>Raymond M</ForeName><Initials>RM</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType>Clinical Trial, Phase I</PublicationType><PublicationType>Journal Article</PublicationType><PublicationType>Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>04</Month><Day>22</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Nucl Med Biol</MedlineTA><NlmUniqueID>9304420</NlmUniqueID><ISSNLinking>0969-8051</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Immunoglobulin Fab Fragments</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Indium Radioisotopes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Radiopharmaceuticals</NameOfSubstance></Chemical><Chemical><RegistryNumber>7A314HQM0I</RegistryNumber><NameOfSubstance>Pentetic Acid</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance>ERBB2 protein, human</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance>Receptor, erbB-2</NameOfSubstance></Chemical><Chemical><RegistryNumber>P188ANX8CK</RegistryNumber><NameOfSubstance>trastuzumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName><QualifierName MajorTopicYN="N">administration & dosage</QualifierName><QualifierName MajorTopicYN="N">chemistry</QualifierName><QualifierName MajorTopicYN="Y">diagnostic use</QualifierName><QualifierName MajorTopicYN="N">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Breast Neoplasms</DescriptorName><QualifierName MajorTopicYN="Y">diagnosis</QualifierName><QualifierName MajorTopicYN="Y">pathology</QualifierName><QualifierName MajorTopicYN="N">radionuclide imaging</QualifierName><QualifierName MajorTopicYN="N">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Feasibility Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Immunoglobulin Fab Fragments</DescriptorName><QualifierName MajorTopicYN="Y">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Indium Radioisotopes</DescriptorName><QualifierName MajorTopicYN="Y">diagnostic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Intraoperative Period</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Pentetic Acid</DescriptorName><QualifierName MajorTopicYN="Y">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N">Radiometry</DescriptorName></MeshHeading><MeshHeading><DescriptorName 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