Lung CancerNCT04217655
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
A study testing Low-dose computed tomography and Standard-dose computed tomography in people with Lung Cancer and Lung; Node, run by Xuzhou Central Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Lung; Node
- What is being tested?
- Low-dose computed tomography and Standard-dose computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 28 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-diagnostic lung lesions (no definitive pathological diagnosis);
- Lesion size between 5 and 30 mm;
- Solid lung lesions.
Who cannot join
- The lesion which has been punctured previously;
- A lesion that had shrunk in size or a lesion with a stable size for 1 year;
- Severe dysfunction in heart, lung and coagulation function;
- Patients who refused to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About 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.
Read the detailed 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.
- Conditions
- Lung Cancer, Lung; Node
- Being tested
- Low-dose computed tomography, Standard-dose computed tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomographyDiagnostic test
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Standard-dose computed tomographyDiagnostic test
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose computed tomography group | Experimental | Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1. Receives: Diagnostic Test: Low-dose computed tomography |
| Standard-dose computed tomography group | Active comparator | Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1. Receives: Diagnostic Test: Standard-dose computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months
Secondary outcomes (1)
Radiation dose
Radiation dose is the radiation exposure from the computed tomography device to patients.
Measured: From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xian-Chi Li, MD, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217655
- Sponsor's protocol ID
- 20200102-001
- Status last verified
- Dec 2021
- First submitted
- 1 Jan 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
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.
PubMed 31776740Li EL, Ma AL, Wang T, Fu YF, Liu HY, Li GC. Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial. J Cardiothorac Surg. 2023 Mar 16;18(1):86. doi: 10.1186/s13019-023-02183-8.
PubMed 36927419
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
- ClinicalTrials.gov ID
- NCT04217655
- Acronym / sponsor ID
- 20200102-001
- Conditions
- Lung Cancer, Lung; Node
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose computed tomography group | Experimental | Diagnostic Test: Low-dose computed tomographyPatients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1. |
| Standard-dose computed tomography group | Active comparator | Diagnostic Test: Standard-dose computed tomographyPatients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-diagnostic lung lesions (no definitive pathological diagnosis);
- Lesion size between 5 and 30 mm;
- Solid lung lesions.
Key exclusion criteria (4 listed)
- The lesion which has been punctured previously;
- A lesion that had shrunk in size or a lesion with a stable size for 1 year;
- Severe dysfunction in heart, lung and coagulation function;
- Patients who refused to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose computed tomographyRadiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds) | Diagnostic test | Low-dose computed tomography group |
| Standard-dose computed tomographyRadiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds) | Diagnostic test | Standard-dose computed tomography group |
Primary outcome
Diagnostic accuracy
Time frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months
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.
1 secondary outcome
Radiation dose
Time frame: From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 31776740Fu 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.
- Derived from this study: PubMed 36927419Li EL, Ma AL, Wang T, Fu YF, Liu HY, Li GC. Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial. J Cardiothorac Surg. 2023 Mar 16;18(1):86. doi: 10.1186/s13019-023-02183-8.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
Related trials for Lung Cancer
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
Enrolling by invitationObservational study
Patient Reported Outcomes Following Percutaneous Lung Ablation
Lung Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Chi Li, MD principal investigator
Xuzhou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose computed tomography and Standard-dose computed tomography in people with Lung Cancer and Lung; Node, run by Xuzhou Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.