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mCBCT in Combination With ENB for the Diagnosis of PPNs

China109 participantsStarted 2022-09-26

Plain-language summary

This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject with age of 18 years and older * Chest CT imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology * Pulmonary nodules of \> 8mm and ≤30 mm in largest dimension * Patients without contraindications of bronchoscopy * Patients have good medical adherence and signed informed consent Exclusion Criteria: * Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy * Presence of concomitant endobronchial lesion during the bronchoscopy procedure * Pre-operative mCBCT spin scan showed no visible lesions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic yield improvement ratio

Timeframe: Up to at least 6 months

Trial details

NCT IDNCT05518669

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Jiayuan Sun, MD, PhD

86-21-22200000 jysun1976@163.com

View on ClinicalTrials.gov More Peripheral Pulmonary Nodules trials