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Compares treatment options for Stage IA Lung Cancer
Official title Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
ClinicalTrials.gov ID: NCT06052098
What this study is testing
- What it's testing
- The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
You likely can't join if
- Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
- Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that...
- Patients with poorly controlled malignant pleural effusion.
- Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less...
See the full eligibility criteria
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
- Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
- Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
- Patients with poorly controlled malignant pleural effusion.
- Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
- Eastern Cooperative Oncology Group (ECOG) score \> 2.
- Combined with other tumors with extensive metastasis, expected survival \< 6 months.
- Patients with episodic psychosis.
- Patients with implantable electronic devices (such as pacemaker or defibrillator).
- Pregnant women, or patients who have pregnancy plans during the study.
- Participation or ongoing participation in another clinical study within the past 30 days.
- Other situations that the investigator deems inappropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.