Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy (CTIH)
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|ClinicalTrials.gov Identifier: NCT02815553|
Recruitment Status : Unknown
Verified May 2016 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, malignant tumors are hard to completely resect. Also, as thoracoscopic surgeries induce great operation trauma, some patients cannot tolerate or do not will to take the operation. Therefore, new methods and techniques are in urgent need.
Our center have a 12-year experience of intervention treatment for solid tumors and has conducted several animal experiments to verify the effectiveness of transthoracic puncture ablation and radiofrequency ablation for ventricular muscle.
The purpose of this study is to conduct new method of direct transthoracic cardiac tumor-targeted Radiofrequency Ablation (RFA) and Laser induced Interstitial Thermotherapy (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the safety and validity of intervention treatment in long term.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Tumors||Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||May 2018|
|Experimental: Cardiac tumors||
Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy
Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy
- Mortality [ Time Frame: 24 months ]
- Tumor size [ Time Frame: 24 months ]If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.
- Quantification of obstructive severity [ Time Frame: 24 months ]Investigators use the peak velocity and of stenosis (by echocardiography) to quantify obstructive severity caused by the tumor. If the peak velocity increases, the symptom gets deteriorated; if the peak velocity decreases, the symptom gets relieved.
- Quantification of lung function [ Time Frame: 24 months ]Investigators use diffusion function to quantify the lung function.
- Quantification of cardiac function [ Time Frame: 24 months ]Investigators use ejection fraction(EF) to quantify the cardiac function. If EF is higher after the operation, the cardiac function gets recovered; if EF is lower after the operation,the cardiac function does't get recovered.
- Quantification of tumor blood perfusion [ Time Frame: 24 months ]Investigators use contrast-enhanced ultrasonography to quantify tumor blood perfusion. If there is no perfusion observed, the therapy is successful；if there is perfusion, the therapy is ineffective.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815553
|Contact: Liwen Liu, MDemail@example.com|
|Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Liwen Liu, MD|