Comparison of the Diagnostic Accuracy: US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions

NCT06412289 | Recruiting

• 1 other identifier: 648/2023/Sper/AOUFe
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief Summary

A non-sponsored prospective randomized single-blind national multicenter interventional study which aims to compare the diagnostic accuracy between US-guided percutaneous lung needle biopsies and CT-guided in peripheral lung lesions. Secondary endpoints are:

• onset of number and type of complications during and after the procedure, within the first three hour;
• exposition to ionizing radiation, in milligray(mGy);
• patient comfort during the procedure;
• duration of the procedure,

Conditions

Peripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

• Rate of diagnostic samples vs rate of non diagnostic samples assessed by the histological reports, detecting the ones positive for malignant neoplasm or specific benign process out of the totality of procedures for both US-guided and CT-guided biopsy

  For diagnostic sampling is meant the ability to diagnose a malignant neoplasm or a specific benign process (such as benignant neoplasia, granulomatous inflammation). For nondiagnostic sample is meant the finding of a non-specific benign process or that the sample is not adequate/sufficient. For benign non-specific is meant a histological diagnosis suggesting a benign process without any evidence of malignancy but that does not give the specific information to achieve a definitive diagnosis. In any case that does not include a diagnostic confirmation of a non-specific benign lesion by a surgical approach, TTNA will be considered a true negative only after a follow-up documenting a downsizing of at least 20% in the major axial diameter or a stability in sizing for at least one year from the lesion itself.

  1 month

Secondary Outcomes (5)

• Rate of complications that can be occur during the procedures assessed by physiological parameter, VAS scale, radiography

  3 hours

• Amount of Ionizing radiation to which the patient is exposed calculated in mGy

  1 hour

• Comfort of the patient during the procedure assessed by Visual Analog Pain Scale(VAS scale)

  1 hour

• Duration of the procedure in seconds

  1 hour

• Rate of sample suitable for next-generation sequencing(NGS) analysis based on percentage of neoplastic cell in samples

  1 month

Study Arms (2)

US-guided percutaneous needle biopsy

EXPERIMENTAL

Patients who are randomized into this arm will undergo US-percutaneous needle biopsy to sample the lesion. A convex probe is used to visualize the lung lesion and execute the percutaneous procedure. One hour after the end of the procedure, a chest x-ray is requested.

Diagnostic Test: US-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY

CT-guided percutaneous needle biopsy

EXPERIMENTAL

Patients who are randomized into this arm will undergo CT-percutaneous needle biopsy. The procedure is done by using a CT scan to measure and identify the right point where the percutaneous biopsy will be executed. One hour after the end of the procedure, a chest x-ray is requested.

Diagnostic Test: CT-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY

Interventions

US-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY DIAGNOSTIC_TEST

The ultrasound investigation will be conducted using the ultrasound machine supplied to the Center involved in the trial and usually used in eTTNA procedures. Before the procedure, the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling, based on the location of the lesion. The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field. At this point, local anesthesia with a maximum of 20ml of 2% lidocaine will be administrated, marking down this time as the time of the beginning of the procedure. 18 Gauge needles will be used to collect the sample. For each patient, there will be collected a minimum number of one and a maximum number of three bioptic sampling .

US-guided percutaneous needle biopsy

CT-GUIDED PERCUTANEOUS LUNG NEEDLE BIOPSY DIAGNOSTIC_TEST

The CT scan will be performed using the CT machinery equipped by the Center involved in the trial and usually used for the tTTNA procedures. Before the procedure, the vital signs of the patient will be noted and each operator will choose the most appropriate position for the sampling, based on the location of the lesion. The thoracic area to biopsy will then be defined and then there will be the setting of the sterile field. At this point, local anesthesia with a maximum of 20ml of 2% lidocaine will be administrated, marking down this time as the time of the beginning of the procedure. 18 Gauge needles will be used to collect the sample. For each patient, there will be collected a minimum number of one and a maximum number of three bioptic sampling .

CT-guided percutaneous needle biopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (2)

UO Pneumologia AOSP-AUSL

Ferrara, 44124, Italy

RECRUITING

UOC Pneumologia - Azienda ospedaliera A. Cardarelli

Napoli, 80131, Italy

RECRUITING

Related Publications (14)

• Asano F. Advanced bronchoscopy for the diagnosis of peripheral pulmonary lesions. Respir Investig. 2016 Jul;54(4):224-9. doi: 10.1016/j.resinv.2015.11.008. Epub 2016 Mar 2.

  PMID: 27424820 BACKGROUND

• Wang B, Zhong F, An W, Liao M. The diagnostic value of CT-guided percutaneous puncture biopsy of pulmonary ground-glass nodules: a meta-analysis. Acta Radiol. 2023 Apr;64(4):1431-1438. doi: 10.1177/02841851221137693. Epub 2022 Nov 15.

  PMID: 36380521 BACKGROUND

• Baratella E, Cernic S, Minelli P, Furlan G, Crimi F, Rocco S, Ruaro B, Cova MA. Accuracy of CT-Guided Core-Needle Biopsy in Diagnosis of Thoracic Lesions Suspicious for Primitive Malignancy of the Lung: A Five-Year Retrospective Analysis. Tomography. 2022 Nov 25;8(6):2828-2838. doi: 10.3390/tomography8060236.

  PMID: 36548528 BACKGROUND

• Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.

  PMID: 32023078 BACKGROUND

• Yamamoto N, Watanabe T, Yamada K, Nakai T, Suzumura T, Sakagami K, Yoshimoto N, Sato K, Tanaka H, Mitsuoka S, Asai K, Kimura T, Kanazawa H, Hirata K, Kawaguchi T. Efficacy and safety of ultrasound (US) guided percutaneous needle biopsy for peripheral lung or pleural lesion: comparison with computed tomography (CT) guided needle biopsy. J Thorac Dis. 2019 Mar;11(3):936-943. doi: 10.21037/jtd.2019.01.88.

  PMID: 31019783 BACKGROUND

• Ikezoe J, Sone S, Higashihara T, Morimoto S, Arisawa J, Kuriyama K. Sonographically guided needle biopsy for diagnosis of thoracic lesions. AJR Am J Roentgenol. 1984 Aug;143(2):229-34. doi: 10.2214/ajr.143.2.229.

  PMID: 6611048 BACKGROUND

• Niu XK, Bhetuwal A, Yang HF. CT-guided core needle biopsy of pleural lesions: evaluating diagnostic yield and associated complications. Korean J Radiol. 2015 Jan-Feb;16(1):206-12. doi: 10.3348/kjr.2015.16.1.206. Epub 2015 Jan 9.

  PMID: 25598692 BACKGROUND

• Koegelenberg CF, Irusen EM, von Groote-Bidlingmaier F, Bruwer JW, Batubara EM, Diacon AH. The utility of ultrasound-guided thoracentesis and pleural biopsy in undiagnosed pleural exudates. Thorax. 2015 Oct;70(10):995-7. doi: 10.1136/thoraxjnl-2014-206567. Epub 2015 May 21.

  PMID: 25997433 BACKGROUND

• Knox D, Halligan K. Case series of trans-thoracic nodule aspirate performed by interventional pulmonologists. Respir Med Case Rep. 2021 Feb 2;32:101362. doi: 10.1016/j.rmcr.2021.101362. eCollection 2021.

  PMID: 33665077 BACKGROUND

• Lim C, Lee KY, Kim YK, Ko JM, Han DH. CT-guided core biopsy of malignant lung lesions: how many needle passes are needed? J Med Imaging Radiat Oncol. 2013 Dec;57(6):652-6. doi: 10.1111/1754-9485.12054. Epub 2013 Apr 1.

  PMID: 24283552 BACKGROUND

• Manhire A, Charig M, Clelland C, Gleeson F, Miller R, Moss H, Pointon K, Richardson C, Sawicka E; BTS. Guidelines for radiologically guided lung biopsy. Thorax. 2003 Nov;58(11):920-36. doi: 10.1136/thorax.58.11.920. No abstract available.

  PMID: 14586042 BACKGROUND

• Moore W, Sawas A,Lee C,Ferretti J,

  BACKGROUND

• Kim D, Han JY, Baek JW, Lee HY, Cho HJ, Heo YJ, Shin GW. Effect of the respiratory motion of pulmonary nodules on CT-guided percutaneous transthoracic needle biopsy. Acta Radiol. 2023 Jul;64(7):2245-2252. doi: 10.1177/02841851221144616. Epub 2022 Dec 27.

  PMID: 36575592 BACKGROUND

• DiBardino DM, Yarmus LB, Semaan RW. Transthoracic needle biopsy of the lung. J Thorac Dis. 2015 Dec;7(Suppl 4):S304-16. doi: 10.3978/j.issn.2072-1439.2015.12.16.

  PMID: 26807279 BACKGROUND

Study Officials

• Mario Tamburrini, Dr.

  Arcispedale Sant'Anna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludovica Tamburrini, Dr

CONTACT

3337944389; ludovica.rizzo14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: anatomopathologist is blinded about the procedure which has been executed
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 14, 2024
• Study Start: March 8, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

IT (2)