Can one needle biopsy and freeze lung nodules in a single visit?
NCT ID NCT07806981
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This study tests whether a very thin freezing needle can safely biopsy and destroy suspicious lung nodules in one procedure. About 30 adults with small lung nodules who are not candidates for or decline surgery will undergo the combined approach under CT guidance. Researchers will check if the freezing zone fully covers the nodule, if the biopsy samples are good enough for diagnosis, and how well the nodules are controlled over up to 36 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18G ultrafine cryoablation needle
- What this could lead to
- If it works, this could offer a one-session option for people with suspicious lung nodules who cannot or choose not to have surgery, potentially controlling the disease locally.
- What could go wrong
- This is an early, small study with only 30 participants, so results may not apply broadly. The procedure carries risks like bleeding or lung collapse, and it is unclear if freezing after biopsy will reliably control the nodules long-term.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Apr 2030
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 Hide 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.
Inclusion Criteria: * Age 18 years or older. * One or more pulmonary nodules measuring 3 cm or less on chest CT and considered highly suspicious for malignancy after multidisciplinary review. * The participant is unsuitable for or declines surgery and radiotherapy after multidisciplinary evaluation and shared decision-making. * A safe percutaneous access route is available, and the planned ablation zone can cover the target lesion. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Expected survival of at least 12 months. * The participant or legally authorized representative voluntarily provides written informed consent. Exclusion Criteria: * Platelet count below 50 × 10\^9/L, clinically significant bleeding tendency, or uncorrectable coagulation disorder. * Severe pulmonary fibrosis, pulmonary hypertension, or other severe cardiac, pulmonary, hepatic, renal, neurologic, or systemic organ dysfunction that makes the procedure unsafe. * Uncontrolled local or systemic infection, including uncontrolled infection near the lesion or access site, or fever above 38.5°C. * Poorly controlled malignant pleural effusion. * Anticoagulant or antiplatelet therapy cannot be safely managed before the procedure according to institutional policy. * Pregnancy or a plan to become pregnant during the study. * Active serious psychiatric illness that may interfere with informed consent or study participation. * Participation in another clinical study within 30 days before enrollment. * Any other condition that, in the investigator's judgment, makes participation inappropriate.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary nodules are added.
By submitting, you agree to our Terms of use
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI texts may nudge patients with High-Risk lung nodules toward timely care
- Which comes first? a trial tests the best sequence for lung nodule biopsies.
- Can a freezing needle outperform standard biopsy for lung nodules?
- Can a CT-Free navigation system pinpoint lung nodules with precision?
- AI showdown: three computer models battle to predict lung cancer from CT scans
- 3D-Printed airways could make lung surgery safer