Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04217655
Other study ID # 20200102-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date December 28, 2021

Study information

Verified date December 2021
Source Xuzhou Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.


Description:

At present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. Therefore, it might expose the patients to more radiation. However, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking. In this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 28, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Non-diagnostic lung lesions (no definitive pathological diagnosis); 2. Lesion size between 5 and 30 mm; 3. Solid lung lesions. Exclusion Criteria: 1. The lesion which has been punctured previously; 2. A lesion that had shrunk in size or a lesion with a stable size for 1 year; 3. Severe dysfunction in heart, lung and coagulation function; 4. Patients who refused to provide informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Low-dose computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Standard-dose computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Locations

Country Name City State
China Xuzhou Central Hospital Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary Radiation dose Radiation dose is the radiation exposure from the computed tomography device to patients. From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk