Lung Cancer (Diagnosis)NCT07255950
Accuracy Between Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients
A study testing Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in people with Lung Cancer (Diagnosis) and Biopsy, Fine-Needle/Methods, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Biopsy, Fine-Needle/Methods
- What is being tested?
- Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jul 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Gadjah Mada Academic Hospital (RSA UGM)
Yogyakarta, Special Region of Yogyakarta, 55291
dr. Roihan Mohamad Iqbal, +6285933626780, roihan.iqbal@gmail.com
dr. Siswanto, Sp.P(K)Onk
About this study
Official title: 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
Read the 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.
- Being tested
- Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques
- Keywords
- NSCLC, Non-small cell lung cancer, Transthoracal needle aspiration, Biopsy, Diagnostics
- Medical subject headings
- Lung Neoplasms, Disease, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) TechniquesDiagnostic test
Each of patient will undergo three types of different transthoracal needle aspiration (TTNA)
| Study group | Role | What they receive |
|---|---|---|
| Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) | Experimental | Not described Receives: Diagnostic Test: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate after biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start15 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patient undergo the same intervention
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siswanto Siswanto, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255950
- Sponsor's protocol ID
- KE/0943/06/2025
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) collected during the trial reported in the article will be shared, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Between Jabbing-then-suction, Suction-with-jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07255950
- Acronym / sponsor ID
- KE/0943/06/2025
- Keywords
- NSCLC, Non-small cell lung cancer, Transthoracal needle aspiration, Biopsy, Diagnostics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patient undergo the same intervention
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Patient refuses lung biopsy
- Non-cooperative patient
- Patient with respiratory failure, on positive pressure ventilation
- Severe pulmonary emphysema
- Contralateral pneumonectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) TechniquesEach of patient will undergo three types of different transthoracal needle aspiration (TTNA) | Diagnostic test | Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) |
Primary outcome
Quality of samples from different types of transthoracal needle aspiration (TTNA) technique
Time frame: Immediate after biopsy procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) collected during the trial reported in the article will be shared, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in people with Lung Cancer (Diagnosis) and Biopsy, Fine-Needle/Methods, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr. Roihan Mohamad Iqbal (+6285933626780, roihan.iqbal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of samples from different types of transthoracal needle aspiration (TTNA) technique (time frame: Immediate after biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.