Hepatocellular CarcinomaNCT05270642
Plan for Microwave Thermal Field
A study testing Microwave Thermal guided by Plan for Microwave Thermal Field system in people with Hepatocellular Carcinoma and Ablation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Ablation
- What is being tested?
- Microwave Thermal guided by Plan for Microwave Thermal Field system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy or clinical diagnosis of HCC
- Complete clinical information and preoperative CEUS
- Curative treatment
Who cannot join
- Palliative care
- Intolerance to ablation
- Severe coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on Intelligent System of Plan for Microwave Thermal Field for Hepatocellular Carcinoma
Develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma
- Conditions
- Hepatocellular Carcinoma, Ablation
- Being tested
- Microwave Thermal guided by Plan for Microwave Thermal Field system
- Keywords
- hepatocellular Carcinoma, microwave ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Thermal guided by Plan for Microwave Thermal Field systemProcedure or surgery
When HCC patients undergo microwave ablation, the doctor will refer to the ablation plan provided by the system.If the plan is consistent with what the doctor thinks, follow the plan provided by the system. If the protocol is not consistent with what the doctor thinks, the doctor will revise the protocol.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients guided by Plan for Microwave Thermal Field | Experimental | The plan for HCC patients undergoing microwave ablation would be refer to Plan for Microwave Thermal Field system Receives: Procedure: Microwave Thermal guided by Plan for Microwave Thermal Field system |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI within 3 days after ablation
Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
Measured: MRI within 3 days after ablation
local tumor progression
Follow up to observe whether local tumor progression occurs within 6 months after ablation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Oct 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270642
- Sponsor's protocol ID
- S2021-439-01
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Intelligent System of Plan for Microwave Thermal Field for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05270642
- Acronym / sponsor ID
- S2021-439-01
- Conditions
- Hepatocellular Carcinoma, Ablation
- Keywords
- hepatocellular Carcinoma, microwave ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Mar 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.
Develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients guided by Plan for Microwave Thermal Field | Experimental | Procedure: Microwave Thermal guided by Plan for Microwave Thermal Field systemThe plan for HCC patients undergoing microwave ablation would be refer to Plan for Microwave Thermal Field system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy or clinical diagnosis of HCC
- Complete clinical information and preoperative CEUS
- Curative treatment
Key exclusion criteria (3 listed)
- Palliative care
- Intolerance to ablation
- Severe coagulation disorder
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 |
|---|---|---|
| Microwave Thermal guided by Plan for Microwave Thermal Field systemWhen HCC patients undergo microwave ablation, the doctor will refer to the ablation plan provided by the system.If the plan is consistent with what the doctor thinks, follow the plan provided by the system. If the protocol is not consistent with what the doctor thinks, the doctor will revise the protocol. | Procedure or surgery | HCC patients guided by Plan for Microwave Thermal Field |
Primary outcome
MRI within 3 days after ablation
Time frame: MRI within 3 days after ablation
Postoperative MRI is used to determine whether the ablation zone completely covers the tumor and whether the size is appropriate
local tumor progression
Time frame: 6 months
Follow up to observe whether local tumor progression occurs within 6 months after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Thermal guided by Plan for Microwave Thermal Field system in people with Hepatocellular Carcinoma and Ablation, run by Chinese PLA General 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 3 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 8 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI within 3 days after ablation (time frame: MRI within 3 days after ablation). The study lists 2 primary outcomes in all. 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 8 Mar 2022.