Low-dose Protocol for Computed Tomography-guided Lung Biopsy
NCT ID: NCT02971176
Last Updated: 2019-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
280 participants
INTERVENTIONAL
2016-11-30
2019-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
NCT04217655
Early Stage Lung Cancer Screening With Low-dose Computed Tomographic
NCT02898441
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
NCT04156360
Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer
NCT02941003
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
NCT05617742
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-dose protocol
Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.
Low-dose protocol computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Standard-dose protocol
Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
Standard-dose protocol computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low-dose protocol computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Standard-dose protocol computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xuzhou Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zi-Qi Tao, MD
Role: PRINCIPAL_INVESTIGATOR
Science and Education Division of Xuzhou Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Fu YF, Li GC, Xu QS, Shi YB, Wang C, Wang T. Computed tomography-guided lung biopsy: a randomized controlled trial of low-dose versus standard-dose protocol. Eur Radiol. 2020 Mar;30(3):1584-1592. doi: 10.1007/s00330-019-06464-6. Epub 2019 Nov 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20161115-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.