Cardiac TumorsCTIHNCT02815553
Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy
A study testing Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy and Direct Transthoracic Cardiac Tumor Laser Ablation Therapy in people with Cardiac Tumors, run by Xijing Hospital at 1 site in China.
Trial summary
Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cardiac Tumors
- What is being tested?
- Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy and Direct Transthoracic Cardiac Tumor Laser Ablation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac tumors not suitable for surgical removal
- Subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence
- Cardiac tumors in ventricular chambers, myocardium, or pericardium
- Subject who cannot tolerate thoracoscopic removal or volunteer for the operation
- Subject Over 12 years old
Who cannot join
- Subject who has other cardiac diseases must receive surgical removal
- Subject has end-stage heart failure
- Subject has poor physical conditions and cannot tolerate the operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Liwen Liu, MD
About this study
Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of 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) or 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.
- Conditions
- Cardiac Tumors
- Being tested
- Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy, Direct Transthoracic Cardiac Tumor Laser Ablation Therapy
- Medical subject headings
- Heart Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Transthoracic Cardiac Tumor Radio Frequency Ablation TherapyProcedure or surgery
Direct Transthoracic Cardiac Tumor Laser Ablation TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cardiac tumors | Experimental | Not described Receives: Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy; Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 24 months
Tumor size
If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.
Measured: 24 months
Quantification of obstructive severity
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.
Measured: 24 months
Secondary outcomes (2)
Quantification of cardiac function
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.
Measured: 24 months
Quantification of tumor blood perfusion
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac TumorsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Liwen, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815553
- Sponsor's protocol ID
- KY20162034-1
- Acronym
- CTIH
- Status last verified
- Aug 2022
- First submitted
- 27 May 2016
- Last updated
- 31 Aug 2022
- Results posted
- No
Publications
Huang J, Lei C, Hsi DH, Zheng M, Ma H, Ta S, Hu R, Han C, Li W, Li J, Qu D, Ruan F, Wang J, Wang B, Zhao X, Liu J, Zhao L, Wang Z, Yang J, Liu L. Echocardiography-Guided Radiofrequency Ablation for Cardiac Tumors. JACC CardioOncol. 2024 Apr 30;6(4):560-571. doi: 10.1016/j.jaccao.2024.03.008. eCollection 2024 Aug.
PubMed 39239332
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy
- ClinicalTrials.gov ID
- NCT02815553
- Acronym / sponsor ID
- CTIH / KY20162034-1
- Conditions
- Cardiac Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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.
Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of 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) or 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac tumors | Experimental | Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy, Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cardiac tumors not suitable for surgical removal
- Subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence
- Cardiac tumors in ventricular chambers, myocardium, or pericardium
- Subject who cannot tolerate thoracoscopic removal or volunteer for the operation
- Subject Over 12 years old
Key exclusion criteria (3 listed)
- Subject who has other cardiac diseases must receive surgical removal
- Subject has end-stage heart failure
- Subject has poor physical conditions and cannot tolerate the operation
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 |
|---|---|---|
| Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy | Procedure or surgery | Cardiac tumors |
| Direct Transthoracic Cardiac Tumor Laser Ablation Therapy | Procedure or surgery | Cardiac tumors |
Primary outcome
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.
2 secondary outcomes
Quantification of cardiac function
Time frame: 24 months
Quantification of tumor blood perfusion
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 39239332Huang J, Lei C, Hsi DH, Zheng M, Ma H, Ta S, Hu R, Han C, Li W, Li J, Qu D, Ruan F, Wang J, Wang B, Zhao X, Liu J, Zhao L, Wang Z, Yang J, Liu L. Echocardiography-Guided Radiofrequency Ablation for Cardiac Tumors. JACC CardioOncol. 2024 Apr 30;6(4):560-571. doi: 10.1016/j.jaccao.2024.03.008. eCollection 2024 Aug.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy and Direct Transthoracic Cardiac Tumor Laser Ablation Therapy in people with Cardiac Tumors, run by Xijing Hospital at 1 site in China.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liwen Liu, MD (86-13571975528, liuliwencrt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815553, which also lists 1 linked publication.
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 31 Aug 2022.