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Can a needle through the windpipe beat the knife for early lung cancer?

NCT ID NCT07741344

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether a minimally invasive procedure called bronchoscopic microwave ablation can be as effective as surgery for early-stage lung cancer (stage IA). The procedure uses a bronchoscope to guide a needle to the tumor and destroy it with heat, potentially preserving more lung tissue. The study will compare disease-free survival, lung function, and quality of life between the two approaches in about 292 adults.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bronchoscopic microwave ablation
What this could lead to
If successful, this could establish a less invasive, lung-sparing option for early-stage lung cancer, potentially reducing recovery time and preserving lung function.
What could go wrong
The trial is in Phase 2, and the ablation may not control the cancer as well as surgery. There are risks of incomplete ablation or complications from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 292 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Bronchoscopic Microwave Ablation Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. Determined by multidisciplinary evaluation to be an appropriate candidate for bronchoscopic ablation as part of standard clinical care, and the patient agrees to a lung-preserving treatment approach 4. Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT 5. Tumour located in the middle or peripheral third of the lung parenchyma 6. Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required 7. Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols 8. Pulmonary function results or clinical assessment indicate significant benefit from preserving lung tissue, such as predicted FEV1 or DLCO less than 40%, or clinician judgment that lung preservation is critical for quality of life 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria 1. Presence of lymph node involvement (N1 or higher) or distant metastases (M1) 2. Centrally located tumours within the inner third of the lung or those requiring ablation near major airways 3. Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved 4. Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation 5. Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging 6. Pregnant or breastfeeding women 7. Inability or unwillingness to comply with study procedures 8. Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy 9. Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4 10. Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study Surgical Resection Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection. 4. Tumour size between 2.5 and 3.0 cm, or smaller lesions for which surgery is considered the more appropriate option based on tumour features or safety concerns. 5. Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins. 6. Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging. 7. Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging. 8. Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment Exclusion Criteria 1. Presence of lymph node involvement (N1 or higher) or distant metastases (M1) 2. High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred. 3. Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins). 4. Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection. 5. Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study. 6. Pregnant or breastfeeding women 7. Inability or unwillingness to comply with study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Prince of Wales Hospital

    Hong Kong, Hong Kong