Comparing ultrasound and CT-guided lung biopsies for diagnosing lung lesions
A Prospective, Randomized, Multicentric and Single-blinded Study on Accuracy and Safety of Ultrasound (US) Guided Percutaneous Needle Biopsy of Peripheral Lung Lesion Compared With Computed TomogrAphy (CT) Guided Needle Biopsy
This study is testing whether ultrasound-guided lung biopsies are better or safer than CT-guided biopsies for diagnosing lung lesions in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ferrara and 1 other locations) |
| Trial ID | NCT06412289 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the diagnostic accuracy of ultrasound-guided percutaneous lung biopsies with CT-guided biopsies in patients with peripheral lung lesions. It is a prospective randomized single-blind multicenter interventional study that will assess not only the accuracy of these two methods but also the onset of complications, exposure to ionizing radiation, patient comfort, and the duration of the procedures. The goal is to determine which method provides a safer and more effective means of diagnosing lung lesions, particularly given the increasing incidence of such lesions due to enhanced imaging techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with peripheral pulmonary lesions that are adherent to the thoracic wall as indicated by CT scans.
Not a fit: Patients with terminal neoplastic diseases, severe organ failure, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for lung lesions, reducing complications and enhancing patient comfort.
How similar studies have performed: Previous studies have shown varying success with similar diagnostic approaches, but this specific comparison of ultrasound versus CT guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness and ability to provide free and informed consent. Age older then 18 years old. * Peripheric pulmonary lesions adherent to the thoracic wall in CT scans with indication to typing Exclusion Criteria: * Inability to provide free and informed consent, in the absence of an available legal guardian. * Age younger then 18 years old. * Terminal neoplastic diseases/ palliative care patients. * Patients with one lung, anatomical of functional. * Severe non-treatable blood clothing disfunctions. * Severe organ failure (pulmonary, renal, hepatic or cardiac). * Women in state of pregnancy.
Where this trial is running
Ferrara and 1 other locations
- UO Pneumologia AOSP-AUSL — Ferrara, Italy (Recruiting)
- UOC Pneumologia - Azienda ospedaliera A. Cardarelli — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Mario Tamburrini, Dr. — Arcispedale Sant'Anna
- Study coordinator: Ludovica Tamburrini, Dr
- Email: ludovica.rizzo14@gmail.com
- Phone: 3337944389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.