Accuracy Between Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients

Accuracy Between Jabbing-then-suction, Suction-with-jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients

• The objective of this research is to determine the accuracy of different types of lung transthoracal needle aspiration (TTNA) i.e. jabbing-then-suction, suction-with-jabbing, and suction-only TTNA in patients with suspected lung cancer.
• Researchers will compare these techniques to determine whether there are any quality differences in the obtained tumor samples

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer (Diagnosis); Biopsy, Fine-Needle/Methods
• Intervention / Treatment: Diagnostic test: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques

Detailed Description

During hospitalization for diagnostic testing, suspected lung cancer patients will undergo a transthoracic biopsy using three TTNA techniques, and core needle biopsy as the gold standard. The biopsy is performed in the operating room under local anesthesia and under the supervision of an anesthesiologist. The biopsy techniques used are routine procedures and therefore not as a new method. After the biopsy is completed, the patient is observed for at least 24 hours to observe potential complications.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dr. Roihan Mohamad Iqbal; Phone Number: +6285933626780; Email: roihan.iqbal@gmail.com

Study Locations

• Indonesia
  • Special Region of Yogyakarta
    • Yogyakarta, Special Region of Yogyakarta, Indonesia, 55291
      • Recruiting
      • Universitas Gadjah Mada Academic Hospital (RSA UGM)
      • Contact: dr. Roihan Mohamad Iqbal; Phone Number: +6285933626780; Email: roihan.iqbal@gmail.com
      • Principal Investigator: dr. Siswanto, Sp.P(K)Onk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with suspected lung cancer who will undergo diagnostic testing using ultrasound-guided TTNA of the lung with cell block and core biopsy.
• Patients aged 18-75 years.
• The tumor is located peripherally, attached to the chest wall.

Exclusion Criteria:

• Patient refuses lung biopsy
• Non-cooperative patient
• Patient with respiratory failure, on positive pressure ventilation
• Severe pulmonary emphysema
• Contralateral pneumonectomy
• Advanced pulmonary fibrosis
• Platelet count <100,000/mm3 and international normalized ratio (INR) >1.4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA)	Diagnostic test: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques; Each of patient will undergo three types of different transthoracal needle aspiration (TTNA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of samples from different types of transthoracal needle aspiration (TTNA) technique	To determine the quality of samples between the jabbing-then-suction technique, the suction-with-jabbing technique, and the suction-only technique of transthoracic needle aspiration procedures in patients with unsuspected lung cancer. The sample quality assessed includes the adequacy of the number of tumor cells for molecular examination and the concordance between cytology sample of each type of TTNA technique.	Immediate after biopsy procedure

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; Non-small cell lung cancer; Biopsy; Diagnostics; Transthoracal needle aspiration
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: KE/0943/06/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) collected during the trial reported in the article will be shared, after deidentification.
• IPD Sharing Time Frame: IPD and supporting information will be available immediately following publication, without end date.
• IPD Sharing Access Criteria: Requestors who provide a methodologically sound proposal can access the our IPD data. Proposals should be directed to roihan.iqbal@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No