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

NCT07255950 | Recruiting DMC

• 1 other identifier: KE/0943/06/2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Lung Cancer (Diagnosis); Biopsy, Fine-Needle/Methods

Keywords

NSCLC; Non-small cell lung cancer; Transthoracal needle aspiration; Biopsy; Diagnostics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA)

EXPERIMENTAL

Diagnostic Test: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques

Interventions

Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques DIAGNOSTIC_TEST

Each of patient will undergo three types of different transthoracal needle aspiration (TTNA)

Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Universitas Gadjah Mada Academic Hospital (RSA UGM)

Yogyakarta, Special Region of Yogyakarta, 55291, Indonesia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

dr. Roihan Mohamad Iqbal

CONTACT

+6285933626780; roihan.iqbal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The biopsy results, in a form of 20 cc syringe and slide containing the patient's tissue sample, will be labeled with a code by pulmonologist that will be blinded to the pathologist. The pathologist will then assess the adequacy of the cell count for molecular examination, evaluate the histopathological and cytopathological findings. Statisticians who will process the data are unaware of the allocation of each research item.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patient undergo the same intervention

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: December 1, 2025
• Study Start: July 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available immediately following publication, without end date.
• Access Criteria: Requestors who provide a methodologically sound proposal can access the our IPD data. Proposals should be directed to roihan.iqbal@gmail.com

Locations

ID (1)