<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03009318</url>
  </required_header>
  <id_info>
    <org_study_id>81171295</org_study_id>
    <nct_id>NCT03009318</nct_id>
  </id_info>
  <brief_title>MRS and 11C-methionine PET/CT in the Diagnosis of Glioma</brief_title>
  <official_title>Combination of 11C-MET PET and MRS in the Diagnosis of Glioma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MET PET and MRS are often performed as imaging tool for the differential diagnosis of&#xD;
      gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators&#xD;
      tried to combine these two imaging tools to study whether the combination of MET PET and MRS&#xD;
      could raise the diagnosis ability of the radiological diagnosis of gliomas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the combination of MRS and 11C-MET PET/CT</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relationship between 11C-MET PET/CT results and molecular pathogeneses</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>MRS imaging and 11C-MET PET/CT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Each patient underwent both MRS and MET PET before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tumors are confirmed by surgery and pathology</intervention_name>
    <description>Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.</description>
    <arm_group_label>MRS imaging and 11C-MET PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with non-enhancing supratentorial lesions shown by contrast-enhanced MRI&#xD;
&#xD;
          2. No surgery, chemotherapy or radiotherapy history&#xD;
&#xD;
          3. All patients gave written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with infratentorial Neoplasms&#xD;
&#xD;
          2. Patients with enhancing supratentorial lesions&#xD;
&#xD;
          3. Recurrent gliomas after surgery&#xD;
&#xD;
          4. Primary gliomas with history of radiotherapy or chemotherapy&#xD;
&#xD;
          5. History of malignant tumours at any body site&#xD;
&#xD;
          6. Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dongxiao Zhuang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital, Sudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huashan hospital, Fudan university</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ostrom QT, Gittleman H, Liao P, Rouse C, Chen Y, Dowling J, Wolinsky Y, Kruchko C, Barnholtz-Sloan J. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol. 2014 Oct;16 Suppl 4(Suppl 4):iv1-63. doi: 10.1093/neuonc/nou223. No abstract available.</citation>
    <PMID>25304271</PMID>
  </reference>
  <reference>
    <citation>Fouke SJ, Benzinger T, Gibson D, Ryken TC, Kalkanis SN, Olson JJ. The role of imaging in the management of adults with diffuse low grade glioma: A systematic review and evidence-based clinical practice guideline. J Neurooncol. 2015 Dec;125(3):457-79. doi: 10.1007/s11060-015-1908-9. Epub 2015 Nov 3.</citation>
    <PMID>26530262</PMID>
  </reference>
  <reference>
    <citation>Wang W, Hu Y, Lu P, Li Y, Chen Y, Tian M, Yu L. Evaluation of the diagnostic performance of magnetic resonance spectroscopy in brain tumors: a systematic review and meta-analysis. PLoS One. 2014 Nov 13;9(11):e112577. doi: 10.1371/journal.pone.0112577. eCollection 2014.</citation>
    <PMID>25393009</PMID>
  </reference>
  <reference>
    <citation>Martinez-Bisbal MC, Celda B. Proton magnetic resonance spectroscopy imaging in the study of human brain cancer. Q J Nucl Med Mol Imaging. 2009 Dec;53(6):618-30.</citation>
    <PMID>20016453</PMID>
  </reference>
  <reference>
    <citation>Guo J, Yao C, Chen H, Zhuang D, Tang W, Ren G, Wang Y, Wu J, Huang F, Zhou L. The relationship between Cho/NAA and glioma metabolism: implementation for margin delineation of cerebral gliomas. Acta Neurochir (Wien). 2012 Aug;154(8):1361-70; discussion 1370. doi: 10.1007/s00701-012-1418-x. Epub 2012 Jun 23.</citation>
    <PMID>22729482</PMID>
  </reference>
  <reference>
    <citation>Yamasaki F, Takayasu T, Nosaka R, Amatya VJ, Doskaliyev A, Akiyama Y, Tominaga A, Takeshima Y, Sugiyama K, Kurisu K. Magnetic resonance spectroscopy detection of high lipid levels in intraaxial tumors without central necrosis: a characteristic of malignant lymphoma. J Neurosurg. 2015 Jun;122(6):1370-9. doi: 10.3171/2014.9.JNS14106. Epub 2015 Mar 6.</citation>
    <PMID>25748300</PMID>
  </reference>
  <reference>
    <citation>Oz G, Alger JR, Barker PB, Bartha R, Bizzi A, Boesch C, Bolan PJ, Brindle KM, Cudalbu C, Dincer A, Dydak U, Emir UE, Frahm J, Gonzalez RG, Gruber S, Gruetter R, Gupta RK, Heerschap A, Henning A, Hetherington HP, Howe FA, Huppi PS, Hurd RE, Kantarci K, Klomp DW, Kreis R, Kruiskamp MJ, Leach MO, Lin AP, Luijten PR, Marjanska M, Maudsley AA, Meyerhoff DJ, Mountford CE, Nelson SJ, Pamir MN, Pan JW, Peet AC, Poptani H, Posse S, Pouwels PJ, Ratai EM, Ross BD, Scheenen TW, Schuster C, Smith IC, Soher BJ, Tkac I, Vigneron DB, Kauppinen RA; MRS Consensus Group. Clinical proton MR spectroscopy in central nervous system disorders. Radiology. 2014 Mar;270(3):658-79. doi: 10.1148/radiol.13130531.</citation>
    <PMID>24568703</PMID>
  </reference>
  <reference>
    <citation>WRENN FR Jr, GOOD ML, HANDLER P. The use of positron-emitting radioisotopes for the localization of brain tumors. Science. 1951 May 4;113(2940):525-7. doi: 10.1126/science.113.2940.525. No abstract available.</citation>
    <PMID>14828392</PMID>
  </reference>
  <reference>
    <citation>Demetriades AK, Almeida AC, Bhangoo RS, Barrington SF. Applications of positron emission tomography in neuro-oncology: a clinical approach. Surgeon. 2014 Jun;12(3):148-57. doi: 10.1016/j.surge.2013.12.001. Epub 2014 Mar 11.</citation>
    <PMID>24629841</PMID>
  </reference>
  <reference>
    <citation>Herholz K, Holzer T, Bauer B, Schroder R, Voges J, Ernestus RI, Mendoza G, Weber-Luxenburger G, Lottgen J, Thiel A, Wienhard K, Heiss WD. 11C-methionine PET for differential diagnosis of low-grade gliomas. Neurology. 1998 May;50(5):1316-22. doi: 10.1212/wnl.50.5.1316.</citation>
    <PMID>9595980</PMID>
  </reference>
  <reference>
    <citation>Kracht LW, Miletic H, Busch S, Jacobs AH, Voges J, Hoevels M, Klein JC, Herholz K, Heiss WD. Delineation of brain tumor extent with [11C]L-methionine positron emission tomography: local comparison with stereotactic histopathology. Clin Cancer Res. 2004 Nov 1;10(21):7163-70. doi: 10.1158/1078-0432.CCR-04-0262.</citation>
    <PMID>15534088</PMID>
  </reference>
  <reference>
    <citation>Glaudemans AW, Enting RH, Heesters MA, Dierckx RA, van Rheenen RW, Walenkamp AM, Slart RH. Value of 11C-methionine PET in imaging brain tumours and metastases. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):615-35. doi: 10.1007/s00259-012-2295-5. Epub 2012 Dec 12.</citation>
    <PMID>23232505</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 31, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Dongxiao Zhuang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Glioma</keyword>
  <keyword>Magnetic resonance spectroscopy</keyword>
  <keyword>Methionine</keyword>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009318
org study id: 81171295
nct id: NCT03009318
lead sponsor: 
has dmc: Yes
MET PET and MRS are often performed as imaging tool for the differential diagnosis of
      gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators
      tried to combine these two imaging tools to study whether the combination of MET PET and MRS
      could raise the diagnosis ability of the radiological diagnosis of gliomas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of the combination of MRS and 11C-MET PET/CT
time frame: 5 years
measure: The relationship between 11C-MET PET/CT results and molecular pathogeneses
time frame: 5 years
arm group label: MRS imaging and 11C-MET PET/CT
arm group type: Other
description: Each patient underwent both MRS and MET PET before surgery.
intervention type: Other
intervention name: tumors are confirmed by surgery and pathology
description: Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.
arm group label: MRS imaging and 11C-MET PET/CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dongxiao Zhuang, Professor
role: Principal Investigator
affiliation: Huashan Hospital, Sudan University
facility: 
country: China
citation: Ostrom QT, Gittleman H, Liao P, Rouse C, Chen Y, Dowling J, Wolinsky Y, Kruchko C, Barnholtz-Sloan J. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol. 2014 Oct;16 Suppl 4(Suppl 4):iv1-63. doi: 10.1093/neuonc/nou223. No abstract available.
PMID: 25304271
citation: Fouke SJ, Benzinger T, Gibson D, Ryken TC, Kalkanis SN, Olson JJ. The role of imaging in the management of adults with diffuse low grade glioma: A systematic review and evidence-based clinical practice guideline. J Neurooncol. 2015 Dec;125(3):457-79. doi: 10.1007/s11060-015-1908-9. Epub 2015 Nov 3.
PMID: 26530262
citation: Wang W, Hu Y, Lu P, Li Y, Chen Y, Tian M, Yu L. Evaluation of the diagnostic performance of magnetic resonance spectroscopy in brain tumors: a systematic review and meta-analysis. PLoS One. 2014 Nov 13;9(11):e112577. doi: 10.1371/journal.pone.0112577. eCollection 2014.
PMID: 25393009
citation: Martinez-Bisbal MC, Celda B. Proton magnetic resonance spectroscopy imaging in the study of human brain cancer. Q J Nucl Med Mol Imaging. 2009 Dec;53(6):618-30.
PMID: 20016453
citation: Guo J, Yao C, Chen H, Zhuang D, Tang W, Ren G, Wang Y, Wu J, Huang F, Zhou L. The relationship between Cho/NAA and glioma metabolism: implementation for margin delineation of cerebral gliomas. Acta Neurochir (Wien). 2012 Aug;154(8):1361-70; discussion 1370. doi: 10.1007/s00701-012-1418-x. Epub 2012 Jun 23.
PMID: 22729482
citation: Yamasaki F, Takayasu T, Nosaka R, Amatya VJ, Doskaliyev A, Akiyama Y, Tominaga A, Takeshima Y, Sugiyama K, Kurisu K. Magnetic resonance spectroscopy detection of high lipid levels in intraaxial tumors without central necrosis: a characteristic of malignant lymphoma. J Neurosurg. 2015 Jun;122(6):1370-9. doi: 10.3171/2014.9.JNS14106. Epub 2015 Mar 6.
PMID: 25748300
citation: Oz G, Alger JR, Barker PB, Bartha R, Bizzi A, Boesch C, Bolan PJ, Brindle KM, Cudalbu C, Dincer A, Dydak U, Emir UE, Frahm J, Gonzalez RG, Gruber S, Gruetter R, Gupta RK, Heerschap A, Henning A, Hetherington HP, Howe FA, Huppi PS, Hurd RE, Kantarci K, Klomp DW, Kreis R, Kruiskamp MJ, Leach MO, Lin AP, Luijten PR, Marjanska M, Maudsley AA, Meyerhoff DJ, Mountford CE, Nelson SJ, Pamir MN, Pan JW, Peet AC, Poptani H, Posse S, Pouwels PJ, Ratai EM, Ross BD, Scheenen TW, Schuster C, Smith IC, Soher BJ, Tkac I, Vigneron DB, Kauppinen RA; MRS Consensus Group. Clinical proton MR spectroscopy in central nervous system disorders. Radiology. 2014 Mar;270(3):658-79. doi: 10.1148/radiol.13130531.
PMID: 24568703
citation: WRENN FR Jr, GOOD ML, HANDLER P. The use of positron-emitting radioisotopes for the localization of brain tumors. Science. 1951 May 4;113(2940):525-7. doi: 10.1126/science.113.2940.525. No abstract available.
PMID: 14828392
citation: Demetriades AK, Almeida AC, Bhangoo RS, Barrington SF. Applications of positron emission tomography in neuro-oncology: a clinical approach. Surgeon. 2014 Jun;12(3):148-57. doi: 10.1016/j.surge.2013.12.001. Epub 2014 Mar 11.
PMID: 24629841
citation: Herholz K, Holzer T, Bauer B, Schroder R, Voges J, Ernestus RI, Mendoza G, Weber-Luxenburger G, Lottgen J, Thiel A, Wienhard K, Heiss WD. 11C-methionine PET for differential diagnosis of low-grade gliomas. Neurology. 1998 May;50(5):1316-22. doi: 10.1212/wnl.50.5.1316.
PMID: 9595980
citation: Kracht LW, Miletic H, Busch S, Jacobs AH, Voges J, Hoevels M, Klein JC, Herholz K, Heiss WD. Delineation of brain tumor extent with [11C]L-methionine positron emission tomography: local comparison with stereotactic histopathology. Clin Cancer Res. 2004 Nov 1;10(21):7163-70. doi: 10.1158/1078-0432.CCR-04-0262.
PMID: 15534088
citation: Glaudemans AW, Enting RH, Heesters MA, Dierckx RA, van Rheenen RW, Walenkamp AM, Slart RH. Value of 11C-methionine PET in imaging brain tumours and metastases. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):615-35. doi: 10.1007/s00259-012-2295-5. Epub 2012 Dec 12.
PMID: 23232505
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Dongxiao Zhuang
investigator title: Professor
mesh term: Glioma