Lung CancerNCT03802266
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
A study testing Electromagnetic Navigation guided transthoracic needle aspiration and CT-guided Transthoracic Needle Aspiration in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule. Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Electromagnetic Navigation guided transthoracic needle aspiration and CT-guided Transthoracic Needle Aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
- Patients who are older than 18 year-old;
- Patients voluntarily join the study and give written informed consent for the study.
Who cannot join
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Large blood vessels or important structures on the puncture path of peripheral lung tumors；
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, MD,PhD, 86-21-22200000 ext. 3902, eddiedong8@hotmail.com
Shuhui Cao, MD, 86-21-22200000 ext. 3909, caosh1994@163.com
About this study
Official title: Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.
Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel
- Conditions
- Lung Cancer
- Being tested
- Electromagnetic Navigation guided transthoracic needle aspiration, CT-guided Transthoracic Needle Aspiration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Navigation guided transthoracic needle aspirationDevice
Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
CT-guided Transthoracic Needle AspirationDevice
Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic Navigation group | Experimental | Electromagnetic Navigation Guided Transthoracic Needle Aspiration Receives: Device: Electromagnetic Navigation guided transthoracic needle aspiration |
| CT group | Active comparator | CT-guided Transthoracic Needle Aspiration Receives: Device: CT-guided Transthoracic Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic rate
Measured: 18 months
Secondary outcomes (2)
Operating time
Measured: 18 months
Adverse events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Third Military Medical University
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
- Investigators
- Hua Zhong, Phd，MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802266
- Sponsor's protocol ID
- Chest 010
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
- ClinicalTrials.gov ID
- NCT03802266
- Acronym / sponsor ID
- Chest 010
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Third Military Medical University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 14 Jan 2019 (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.
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.
Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic Navigation group | Experimental | Device: Electromagnetic Navigation guided transthoracic needle aspirationElectromagnetic Navigation Guided Transthoracic Needle Aspiration |
| CT group | Active comparator | Device: CT-guided Transthoracic Needle AspirationCT-guided Transthoracic Needle Aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
- Patients who are older than 18 year-old;
- Patients voluntarily join the study and give written informed consent for the study.
Key exclusion criteria (3 listed)
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Large blood vessels or important structures on the puncture path of peripheral lung tumors；
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
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 |
|---|---|---|
| Electromagnetic Navigation guided transthoracic needle aspirationPatients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule | Device | Electromagnetic Navigation group |
| CT-guided Transthoracic Needle AspirationPatients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule | Device | CT group |
Primary outcome
Diagnostic rate
Time frame: 18 months
2 secondary outcomes
Operating time
Time frame: 18 months
Adverse events
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Hua Zhong, Phd，MD principal investigator
Shanghai Chest 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 Electromagnetic Navigation guided transthoracic needle aspiration and CT-guided Transthoracic Needle Aspiration in people with Lung Cancer, run by Shanghai Chest 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 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Zhong, Phd，MD (13818200560, eddiedong8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.