Low-dose Protocol for Computed Tomography-guided Lung Biopsy

NCT02971176 | Completed DMC

• 1 other identifier: 20161115-010
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer, Adenocarcinoma; Lung Inflammatory Pseudotumor

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  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.

  From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months

Secondary Outcomes (1)

• Complication

  From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day.

Study Arms (2)

Low-dose protocol

EXPERIMENTAL

Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.

Radiation: Low-dose protocol computed tomography

Standard-dose protocol

ACTIVE COMPARATOR

Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.

Radiation: Standard-dose protocol computed tomography

Interventions

Low-dose protocol computed tomography RADIATION

Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)

Low-dose protocol

Standard-dose protocol computed tomography RADIATION

Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Standard-dose protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.

You may not qualify if:

• The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31776740 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung; Plasma Cell Granuloma, Pulmonary

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zi-Qi Tao, MD

  Science and Education Division of Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 22, 2016
• Study Start: November 30, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)