Hepatocellular CancerNCT05361538
Study of Microwave Spherical Ablation and Traditional Microwave Ablation in Single Hepatocellular Carcinoma ≤5cm
A study testing True circular microwave needle in people with Hepatocellular Cancer and Microwave Ablation, run by Tianjin Third Central Hospital at 1 site in China.
Trial summary
Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Cancer, Microwave Ablation, Microwave Spherical Ablation
- What is being tested?
- True circular microwave needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2022to 1 Jun 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ;
- Age range 18 to 75 years old;
- Single lesion with tumor diameter ≤5cm;
- Patient refuses surgery and determines to undergo microwave ablation
- Liver function Child Pugh A or B;
- No extrahepatic metastasis or portal invasion;
- Patient signs the informed consent.
Who cannot join
- The lesion has received treatment, including local ablation therapy and TACE therapy, etc;
- With portal vein invasion or extrahepatic metastases;
- Patient is with severe cardiopulmonary insufficiency.
- Patient is a pregnant or breastfeeding women.
- Patient is considered to be unsuitable to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
Xiang Jing, MD, 02284112323 ext. +86, dr.jingxiang@aliyun.com
Yan Zhou, MD, 02284118101 ext. +86, zhouyan2626@163.com
About this study
Official title: A Single-center, Prospective Randomized Controlled Study of Microwave Spherical Ablation and Traditional Microwave Ablation in the Treatment of Single Hepatocellular Carcinoma With a Diameter of ≤5cm
Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm.
Read the detailed description
HCC is a serious threat to the health of people，Early treatment of HCC results in a good prognosis for patients. Microwave ablation (MWA) is an important method for the treatment of early HCC. The traditional MWA technology has a long diameter of the ablation foci which is much larger than the transverse diameter, so in order to obtain a sufficient transverse diameter, the long diameter is often too large beyond the tumor boundary. That will cause too much normal liver tissue is unnecessarily damaged, especially for patients with severe liver cirrhosis or patients with liver cirrhosis who have undergone liver resection. In addition, it is easy to cause damage to adjacent vital tissues and organs. Changes in tissue properties during ablation affect the stability of the microwave field, resulting in unpredictable ablation shapes, which may cause omissions during tumor ablation, especially in multiple overlapping ablation, resulting in incomplete ablation, or increasing the risk of local tumor progression after treatment. Microwave spherical ablation (MSA) technology is a new MWA technology. With the help of temperature control technology, field control technology and wave control technology, a single needle can produce predictable spherical ablation lesions. Theoretically, MSA can improve the controllability of the ablation foci, which is suitable for the purpose of conformal ablation of large tumors in clinical practice, thereby minimizing the damage of local thermal ablation to liver tissue and adjacent important organs. However, there are few reports on the comparison of the therapeutic effect of MSA and traditional MWA. This study intends to conduct a prospective randomized controlled study based on the two mature microwave treatment methods of MSA and traditional MWA ablation to explore the effectiveness and safety of MSA in clinical application, providing evidence-based medical evidence for the clinical application of MSA.
- Being tested
- True circular microwave needle
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True circular microwave needleDevice
Use true circular microwave needle for thermal ablation
| Study group | Role | What they receive |
|---|---|---|
| MTA Group | Experimental | Use true circular microwave needle for ultrasound-guided thermal ablation in MSA （microwave spherical ablation） group. Receives: Device: True circular microwave needle |
| MWA Group | No intervention | Use normal microwave needle for ultrasound-guided thermal ablation in MTA （microwave ablation） group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of progression-free survival between MSA and traditional MWA in HCC
Compare the time to tumor progression after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm
Measured: 6 to 12 months
Secondary outcomes (4)
Comparison of the overall survival of MSA and traditional MWA in HCC
Compare the time to of all-cause mortality after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm
Measured: 12 to 60 months
Comparison of local progression rates of MSA and traditional MWA in HCC
Local progression was defined as new lesions with hyperenhancement in the arterial phase and low enhancement in the portal or delayed phase found adjacent to the ablation lesion (≤5 mm) during follow-up. Compare the local progression rates after therapy of MTA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤ 5 cm
Measured: 6 to 12 months
Comparison of complete ablation rates of MSA and traditional MWA in HCC
Complete ablation was defined as the tumor showing no enhancement in three stages on contrast-enhanced imaging. Compare the rate of complete ablation after therapy of MTA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm
Measured: 1 month
Comparison of the complications rate of MSA and traditional MWA in HCC
Compare the rate of the complications during and after the therapy of MSA and traditional MWA in the treatment of patients with single hepatocellular carcinoma with a diameter of ≤5cm
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start22 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiang Jing, Study director, Tianjin Third Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361538
- Sponsor's protocol ID
- drjingxiang005
- Status last verified
- Dec 2022
- First submitted
- 29 Apr 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective Randomized Controlled Study of Microwave Spherical Ablation and Traditional Microwave Ablation in the Treatment of Single Hepatocellular Carcinoma With a Diameter of ≤5cm
- ClinicalTrials.gov ID
- NCT05361538
- Acronym / sponsor ID
- drjingxiang005
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 May 2022 (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.
Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm.
Detailed description
HCC is a serious threat to the health of people，Early treatment of HCC results in a good prognosis for patients. Microwave ablation (MWA) is an important method for the treatment of early HCC. The traditional MWA technology has a long diameter of the ablation foci which is much larger than the transverse diameter, so in order to obtain a sufficient transverse diameter, the long diameter is often too large beyond the tumor boundary. That will cause too much normal liver tissue is unnecessarily damaged, especially for patients with severe liver cirrhosis or patients with liver cirrhosis who have undergone liver resection. In addition, it is easy to cause damage to adjacent vital tissues and organs. Changes in tissue properties during ablation affect the stability of the microwave field, resulting in unpredictable ablation shapes, which may cause omissions during tumor ablation, especially in multiple overlapping ablation, resulting in incomplete ablation, or increasing the risk of local tumor progression after treatment. Microwave spherical ablation (MSA) technology is a new MWA technology. With the help of temperature control technology, field control technology and wave control technology, a single needle can produce predictable spherical ablation lesions. Theoretically, MSA can improve the controllability of the ablation foci, which is suitable for the purpose of conformal ablation of large tumors in clinical practice, thereby minimizing the damage of local thermal ablation to liver tissue and adjacent important organs. However, there are few reports on the comparison of the therapeutic effect of MSA and traditional MWA. This study intends to conduct a prospective randomized controlled study based on the two mature microwave treatment methods of MSA and traditional MWA ablation to explore the effectiveness and safety of MSA in clinical application, providing evidence-based medical evidence for the clinical application of MSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Group | Experimental | Device: True circular microwave needleUse true circular microwave needle for ultrasound-guided thermal ablation in MSA （microwave spherical ablation） group. |
| MWA Group | No intervention | –Use normal microwave needle for ultrasound-guided thermal ablation in MTA （microwave ablation） group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ;
- Age range 18 to 75 years old;
- Single lesion with tumor diameter ≤5cm;
- Patient refuses surgery and determines to undergo microwave ablation
- Liver function Child Pugh A or B;
Key exclusion criteria (5 listed)
- The lesion has received treatment, including local ablation therapy and TACE therapy, etc;
- With portal vein invasion or extrahepatic metastases;
- Patient is with severe cardiopulmonary insufficiency.
- Patient is a pregnant or breastfeeding women.
- Patient is considered to be unsuitable to participate in the study
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 |
|---|---|---|
| True circular microwave needleUse true circular microwave needle for thermal ablation | Device | MTA Group |
Primary outcome
Comparison of progression-free survival between MSA and traditional MWA in HCC
Time frame: 6 to 12 months
Compare the time to tumor progression after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm
4 secondary outcomes
Comparison of the overall survival of MSA and traditional MWA in HCC
Time frame: 12 to 60 months
Comparison of local progression rates of MSA and traditional MWA in HCC
Time frame: 6 to 12 months
Comparison of complete ablation rates of MSA and traditional MWA in HCC
Time frame: 1 month
Comparison of the complications rate of MSA and traditional MWA in HCC
Time frame: immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Xiang Jing study director
Tianjin Third Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True circular microwave needle in people with Hepatocellular Cancer and Microwave Ablation, run by Tianjin Third Central 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 7 inclusion and 5 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 14 Dec 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 Xiang Jing, MD (02284112323, dr.jingxiang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of progression-free survival between MSA and traditional MWA in HCC (time frame: 6 to 12 months). 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 14 Dec 2022.