<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/NCT02971176</url>
  </required_header>
  <id_info>
    <org_study_id>20161115-010</org_study_id>
    <nct_id>NCT02971176</nct_id>
  </id_info>
  <brief_title>Low-dose Protocol for Computed Tomography-guided Lung Biopsy</brief_title>
  <official_title>Low-dose Protocol for Computed Tomography-guided Lung Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the diagnostic accuracy and complication rate between&#xD;
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the comprehensive usage of computed tomography examination, patients are more and more&#xD;
      aware of the radiation dose of computed tomography. Concerns over the potential for radiation&#xD;
      induced malignancies have increasingly been published in the scientific literature and&#xD;
      reported in the popular press. The risk is highest for younger patients, who have more&#xD;
      radiation-sensitive tissues and longer life expectancies than adults. Recently, the United&#xD;
      States Food and Drug Administration announced an initiative to reduce unnecessary radiation&#xD;
      exposure from medical imaging. At present, low-dose computed tomography protocol is widely&#xD;
      used for the diagnosis of cardiovascular and cerebrovascular diseases.&#xD;
&#xD;
      Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and&#xD;
      masses. However, it requires repeating scanning to guide the needles, which inevitably&#xD;
      increases the radiation dose. Therefore, low-dose protocol was also used in the computed&#xD;
      tomography-guided lung biopsy procedure.&#xD;
&#xD;
      The purpose of this study is to compare the diagnostic accuracy and complication rate between&#xD;
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2016</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months</time_frame>
    <description>Diagnostic accuracy is defined as the biopsy diagnosis matches with the final diagnosis. The final diagnosis is made according to the surgical or follow-up findings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day.</time_frame>
    <description>Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Lung Cancer, Adenocarcinoma</condition>
  <condition>Lung Inflammatory Pseudotumor</condition>
  <arm_group>
    <arm_group_label>Low-dose protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-dose protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low-dose protocol computed tomography</intervention_name>
    <description>Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)</description>
    <arm_group_label>Low-dose protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard-dose protocol computed tomography</intervention_name>
    <description>Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)</description>
    <arm_group_label>Standard-dose protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The lesion which has been punctured previously; Severe dysfunction in heart, lung and&#xD;
             coagulation function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zi-Qi Tao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Science and Education Division of Xuzhou Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249.</citation>
    <PMID>19710483</PMID>
  </reference>
  <reference>
    <citation>Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.</citation>
    <PMID>18046031</PMID>
  </reference>
  <reference>
    <citation>Jaffe TA, Yoshizumi TT, Toncheva G, Anderson-Evans C, Lowry C, Miller CM, Nelson RC, Ravin CE. Radiation dose for body CT protocols: variability of scanners at one institution. AJR Am J Roentgenol. 2009 Oct;193(4):1141-7. doi: 10.2214/AJR.09.2330.</citation>
    <PMID>19770340</PMID>
  </reference>
  <reference>
    <citation>Gnannt R, Winklehner A, Goetti R, Schmidt B, Kollias S, Alkadhi H. Low kilovoltage CT of the neck with 70 kVp: comparison with a standard protocol. AJNR Am J Neuroradiol. 2012 Jun;33(6):1014-9. doi: 10.3174/ajnr.A2910. Epub 2012 Feb 2.</citation>
    <PMID>22300930</PMID>
  </reference>
  <reference>
    <citation>Zhang LJ, Qi L, De Cecco CN, Zhou CS, Spearman JV, Schoepf UJ, Lu GM. High-pitch coronary CT angiography at 70 kVp with low contrast medium volume: comparison of 80 and 100 kVp high-pitch protocols. Medicine (Baltimore). 2014 Nov;93(22):e92. doi: 10.1097/MD.0000000000000092.</citation>
    <PMID>25396334</PMID>
  </reference>
  <reference>
    <citation>Neefjes LA, Dharampal AS, Rossi A, Nieman K, Weustink AC, Dijkshoorn ML, Ten Kate GJ, Dedic A, Papadopoulou SL, van Straten M, Cademartiri F, Krestin GP, de Feyter PJ, Mollet NR. Image quality and radiation exposure using different low-dose scan protocols in dual-source CT coronary angiography: randomized study. Radiology. 2011 Dec;261(3):779-86. doi: 10.1148/radiol.11110606. Epub 2011 Oct 3.</citation>
    <PMID>21969666</PMID>
  </reference>
  <reference>
    <citation>Chen GZ, Zhang LJ, Schoepf UJ, Wichmann JL, Milliken CM, Zhou CS, Qi L, Luo S, Lu GM. Radiation dose and image quality of 70 kVp cerebral CT angiography with optimized sinogram-affirmed iterative reconstruction: comparison with 120 kVp cerebral CT angiography. Eur Radiol. 2015 May;25(5):1453-63. doi: 10.1007/s00330-014-3533-y. Epub 2015 Jan 31.</citation>
    <PMID>25636415</PMID>
  </reference>
  <reference>
    <citation>Nour-Eldin NE, Alsubhi M, Emam A, Lehnert T, Beeres M, Jacobi V, Gruber-Rouh T, Scholtz JE, Vogl TJ, Naguib NN. Pneumothorax Complicating Coaxial and Non-coaxial CT-Guided Lung Biopsy: Comparative Analysis of Determining Risk Factors and Management of Pneumothorax in a Retrospective Review of 650 Patients. Cardiovasc Intervent Radiol. 2016 Feb;39(2):261-70. doi: 10.1007/s00270-015-1167-3. Epub 2015 Jul 7.</citation>
    <PMID>26148648</PMID>
  </reference>
  <reference>
    <citation>Nour-Eldin NE, Alsubhi M, Naguib NN, Lehnert T, Emam A, Beeres M, Bodelle B, Koitka K, Vogl TJ, Jacobi V. Risk factor analysis of pulmonary hemorrhage complicating CT-guided lung biopsy in coaxial and non-coaxial core biopsy techniques in 650 patients. Eur J Radiol. 2014 Oct;83(10):1945-52. doi: 10.1016/j.ejrad.2014.06.023. Epub 2014 Jul 5.</citation>
    <PMID>25063212</PMID>
  </reference>
  <reference>
    <citation>Kallianos KG, Elicker BM, Henry TS, Ordovas KG, Nguyen J, Naeger DM. Instituting a Low-dose CT-guided Lung Biopsy Protocol. Acad Radiol. 2016 Sep;23(9):1130-6. doi: 10.1016/j.acra.2016.05.013. Epub 2016 Jun 14.</citation>
    <PMID>27317393</PMID>
  </reference>
  <reference>
    <citation>Adiga S, Athreya S. Safety, efficacy, and feasibility of an ultra-low dose radiation protocol for CT-guided percutaneous needle biopsy of pulmonary lesions: initial experience. Clin Radiol. 2014 Jul;69(7):709-14. doi: 10.1016/j.crad.2014.02.006. Epub 2014 Apr 4.</citation>
    <PMID>24709093</PMID>
  </reference>
  <reference>
    <citation>Smith JC, Jin DH, Watkins GE, Miller TR, Karst JG, Oyoyo UE. Ultra-low-dose protocol for CT-guided lung biopsies. J Vasc Interv Radiol. 2011 Apr;22(4):431-6. doi: 10.1016/j.jvir.2011.01.431.</citation>
    <PMID>21463754</PMID>
  </reference>
  <reference>
    <citation>Meng XX, Kuai XP, Dong WH, Jia NY, Liu SY, Xiao XS. Comparison of lung lesion biopsies between low-dose CT-guided and conventional CT-guided techniques. Acta Radiol. 2013 Oct;54(8):909-15. doi: 10.1177/0284185113485937. Epub 2013 Jul 1.</citation>
    <PMID>23817682</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>June 2, 2019</last_update_submitted>
  <last_update_submitted_qc>June 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
    <mesh_term>Plasma Cell Granuloma, Pulmonary</mesh_term>
    <mesh_term>Granuloma, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make individual participant data available.</ipd_description>
  </patient_data>
  <!-- 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/NCT02971176
org study id: 20161115-010
nct id: NCT02971176
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the diagnostic accuracy and complication rate between
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
With the comprehensive usage of computed tomography examination, patients are more and more
      aware of the radiation dose of computed tomography. Concerns over the potential for radiation
      induced malignancies have increasingly been published in the scientific literature and
      reported in the popular press. The risk is highest for younger patients, who have more
      radiation-sensitive tissues and longer life expectancies than adults. Recently, the United
      States Food and Drug Administration announced an initiative to reduce unnecessary radiation
      exposure from medical imaging. At present, low-dose computed tomography protocol is widely
      used for the diagnosis of cardiovascular and cerebrovascular diseases.

      Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and
      masses. However, it requires repeating scanning to guide the needles, which inevitably
      increases the radiation dose. Therefore, low-dose protocol was also used in the computed
      tomography-guided lung biopsy procedure.

      The purpose of this study is to compare the diagnostic accuracy and complication rate between
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic accuracy
time frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months
description: Diagnostic accuracy is defined as the biopsy diagnosis matches with the final diagnosis. The final diagnosis is made according to the surgical or follow-up findings.
measure: Complication
time frame: From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day.
description: Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.
arm group label: Low-dose protocol
arm group type: Experimental
description: Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.
arm group label: Standard-dose protocol
arm group type: Active Comparator
description: Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
intervention type: Radiation
intervention name: Low-dose protocol computed tomography
description: Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
arm group label: Low-dose protocol
intervention type: Radiation
intervention name: Standard-dose protocol computed tomography
description: Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
arm group label: Standard-dose protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zi-Qi Tao, MD
role: Principal Investigator
affiliation: Science and Education Division of Xuzhou Central Hospital
facility: 
country: China
citation: Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249.
PMID: 19710483
citation: Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PMID: 18046031
citation: Jaffe TA, Yoshizumi TT, Toncheva G, Anderson-Evans C, Lowry C, Miller CM, Nelson RC, Ravin CE. Radiation dose for body CT protocols: variability of scanners at one institution. AJR Am J Roentgenol. 2009 Oct;193(4):1141-7. doi: 10.2214/AJR.09.2330.
PMID: 19770340
citation: Gnannt R, Winklehner A, Goetti R, Schmidt B, Kollias S, Alkadhi H. Low kilovoltage CT of the neck with 70 kVp: comparison with a standard protocol. AJNR Am J Neuroradiol. 2012 Jun;33(6):1014-9. doi: 10.3174/ajnr.A2910. Epub 2012 Feb 2.
PMID: 22300930
citation: Zhang LJ, Qi L, De Cecco CN, Zhou CS, Spearman JV, Schoepf UJ, Lu GM. High-pitch coronary CT angiography at 70 kVp with low contrast medium volume: comparison of 80 and 100 kVp high-pitch protocols. Medicine (Baltimore). 2014 Nov;93(22):e92. doi: 10.1097/MD.0000000000000092.
PMID: 25396334
citation: Neefjes LA, Dharampal AS, Rossi A, Nieman K, Weustink AC, Dijkshoorn ML, Ten Kate GJ, Dedic A, Papadopoulou SL, van Straten M, Cademartiri F, Krestin GP, de Feyter PJ, Mollet NR. Image quality and radiation exposure using different low-dose scan protocols in dual-source CT coronary angiography: randomized study. Radiology. 2011 Dec;261(3):779-86. doi: 10.1148/radiol.11110606. Epub 2011 Oct 3.
PMID: 21969666
citation: Chen GZ, Zhang LJ, Schoepf UJ, Wichmann JL, Milliken CM, Zhou CS, Qi L, Luo S, Lu GM. Radiation dose and image quality of 70 kVp cerebral CT angiography with optimized sinogram-affirmed iterative reconstruction: comparison with 120 kVp cerebral CT angiography. Eur Radiol. 2015 May;25(5):1453-63. doi: 10.1007/s00330-014-3533-y. Epub 2015 Jan 31.
PMID: 25636415
citation: Nour-Eldin NE, Alsubhi M, Emam A, Lehnert T, Beeres M, Jacobi V, Gruber-Rouh T, Scholtz JE, Vogl TJ, Naguib NN. Pneumothorax Complicating Coaxial and Non-coaxial CT-Guided Lung Biopsy: Comparative Analysis of Determining Risk Factors and Management of Pneumothorax in a Retrospective Review of 650 Patients. Cardiovasc Intervent Radiol. 2016 Feb;39(2):261-70. doi: 10.1007/s00270-015-1167-3. Epub 2015 Jul 7.
PMID: 26148648
citation: Nour-Eldin NE, Alsubhi M, Naguib NN, Lehnert T, Emam A, Beeres M, Bodelle B, Koitka K, Vogl TJ, Jacobi V. Risk factor analysis of pulmonary hemorrhage complicating CT-guided lung biopsy in coaxial and non-coaxial core biopsy techniques in 650 patients. Eur J Radiol. 2014 Oct;83(10):1945-52. doi: 10.1016/j.ejrad.2014.06.023. Epub 2014 Jul 5.
PMID: 25063212
citation: Kallianos KG, Elicker BM, Henry TS, Ordovas KG, Nguyen J, Naeger DM. Instituting a Low-dose CT-guided Lung Biopsy Protocol. Acad Radiol. 2016 Sep;23(9):1130-6. doi: 10.1016/j.acra.2016.05.013. Epub 2016 Jun 14.
PMID: 27317393
citation: Adiga S, Athreya S. Safety, efficacy, and feasibility of an ultra-low dose radiation protocol for CT-guided percutaneous needle biopsy of pulmonary lesions: initial experience. Clin Radiol. 2014 Jul;69(7):709-14. doi: 10.1016/j.crad.2014.02.006. Epub 2014 Apr 4.
PMID: 24709093
citation: Smith JC, Jin DH, Watkins GE, Miller TR, Karst JG, Oyoyo UE. Ultra-low-dose protocol for CT-guided lung biopsies. J Vasc Interv Radiol. 2011 Apr;22(4):431-6. doi: 10.1016/j.jvir.2011.01.431.
PMID: 21463754
citation: Meng XX, Kuai XP, Dong WH, Jia NY, Liu SY, Xiao XS. Comparison of lung lesion biopsies between low-dose CT-guided and conventional CT-guided techniques. Acta Radiol. 2013 Oct;54(8):909-15. doi: 10.1177/0284185113485937. Epub 2013 Jul 1.
PMID: 23817682
responsible party type: Sponsor
mesh term: Adenocarcinoma of Lung
mesh term: Plasma Cell Granuloma, Pulmonary
mesh term: Granuloma, Plasma Cell
sharing ipd: No
ipd description: There is not a plan to make individual participant data available.