Safety and effectiveness of microwave ablation (MWA)as a new thermal ablation technique for lungmalignancies (SAMANTHA)

Not Applicable

• Conditions: C78.0; C34; Secondary malignant neoplasm of lung; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00007163
• Lead Sponsor: Otto-von-Guericke-Universität MagdeburgMedizinische Fakultät

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-19
• Study Completion: 2017-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Primary lung cancer (NSCLC)
o Functional irresectable
•FEV1 < 30% and/or
•diffusion capacity <30% and/or
•mx. O2-uptake in spiro-ergometry < 15% and/or
•EF<30% in echocardiography
and/or
oRefusal of surgical treatment by patient
and/or
oInterdisciplinary decision for microablative treatment

2. Secondary lung malignancies
oInterdisciplinary decision for microablative treatment

- Age > 18 years
- Tumor size between 5mm and 50mm
- Positive proof of vitality:
oFDG-uptake in FDG-PET-CT (positive biopsy needed in case of doubts in a positive PET finding in interdisciplinary consensus)
and/or
osize increase of target lesion in CT
and/or
opositive biopsy of the target lesion
- Distance between target lesion and heart > 20mm

Exclusion Criteria

- Life expectancy <13 month
- Contraindications for a CT-guided intervention
- Contraindications for a microwave ablation
- Abnormal bleeding parameters (PTT < 50%; platelet count < 50x109/L)
- Respiratory insufficiency (pO2 < 60 or pCO2 > 45)
- Myocardial infarction or stroke within 2 month before intervention

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the safety of microwave ablation (MWA) of lung malignancies up to 5cm size.

Secondary Outcome Measures

Name	Time	Method
local control after MWA after 4 months (PET-CT) and 13 months (CT)<br>local control after MWA of lung tumors in direct contact with vessels, measuring 3mm or larger<br>characteristics of CT imaging and PET-CT follow-up after MWA<br>local tumor control in association to COPD