Lung CancerNCT06581107
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures
A study testing CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation in people with Lung Cancer and Thoracic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Thoracic Cancer
- What is being tested?
- CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 28 Feb 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
- Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures;
- Participants voluntarily participate in this clinical study and sign the informed consent form;
- Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer;
- Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required.
Who cannot join
- Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy;
- Participants suffer from extensive pleural metastases with massive pleural effusion;
- Participants have tumors adjacent to the mediastinal blood vessels, contrast allergy, or inability to cooperate, which makes it difficult to choose the route of needle insertion;
- Participants with lesions encircling blood vessels where ablation may lead to severe bleeding;
- Participants with severely impaired lung function, with maximal ventilation <40%;
- Participants with a low platelet count and severe coagulation abnormalities who cannot tolerate the procedure (anticoagulant therapy and/or anticoagulant medication should be discontinued for more than 1 week prior to ablation therapy);
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- Participants with poor general condition (multiple metastases throughout the body, severe infections, high fever), obvious malignant disease, severe insufficiency of vital organ function, severe anemia, and disorders of nutritional metabolism that cannot be improved in the short term;
- Allergy to contrast media or anesthetics;
- Pregnant or breastfeeding women, or those who plan to have children during the clinical study;
- Participants with known addiction to drugs, alcohol, etc.;
- Participants with psychiatric disorders who have no self-control and are unable to communicate clearly;
- Participants who have participated in other drug, biologic, or medical device clinical studies without meeting the primary study endpoint timeframe prior to enrollment in this study;
- Any other conditions that the investigator deems unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University, Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Haipeng Yu, PhD, 0086-22-23340123, jieruke@163.com
Xueling Yang, PhD, 0086-22-23340123, yxueling123@163.com
About this study
Official title: Validate the Feasibility and Safety of the Robot System by Investgating the CT-fluoroscopy Guidance in Percutaneous Lung Cryablation Procedures of Participants With Lung Cancer
This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance.
The main questions this study aims to answer are:
- Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas;
- Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment;
- Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time;
- Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate;
- Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.
Read the detailed description
Lung cancer is the leading cause of morbidity and mortality of malignant tumors.
The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer (NSCLC), with proven long-term cure rates and survival. However, more than 20% of patients are not eligible for surgical treatment due to comorbidities or poor underlying lung reserve.
With the development of minimally invasive interventional field, lung cancer cryoablation has also become an established tool for the treatment of early stage lung cancer and palliative treatment of advanced lung cancer in recent years.
However, the image-guidance cryoablation method still faces the following challenges:
- Lack of real-time and accurate information during the needle insertion process, including puncture force, needle deformation, soft tissue deformation, and needle arrival position;
- Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area, which leads to prolonged operation time, easily induces complications and increases the radiation dose to the physicians.
- The accuracy of needle insertion is highly affected by the patient's respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs (movement, rotation, etc.), resulting in the drift of the tumour position. Eventually, it is difficult for radiologists to reach the target position, resulting in insufficient ablation areas and increased probability of cancer recurrence.
- The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax
- The procedure is highly dependent on the ability and experience of radiologists.
- Conditions
- Lung Cancer, Thoracic Cancer
- Being tested
- CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
- Keywords
- Image-guided Biopsy; Robot-assisted procedures
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-fluoroscopy guided master-slave intervetional robot-assisted lung CryoablationProcedure or surgery
During the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).
| Study group | Role | What they receive |
|---|---|---|
| Singel arm | Experimental | CT-fluoroscopy guided robot-assisted percutaneous lung Cryoablation group Receives: Procedure: CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
After the cryoablation procedure, the radiologists evaluate the consistency of the postoperative ablation area derived from the immediate postoperative thoracic CT scan with the size of the preoperative planning area. If consistent, it is defined as a technical success. The technical success rate is defined as the ratio of the number of participants with technical success to the total number of enrolled participants.
Measured: The day of the procedure
Secondary outcomes (7)
The number of needle adjustments
The number will be counted when the needle tip angle is altered or the needle is retracted during the procedure.
Measured: The day of the procedure
Number of cryoprobes used
The number of cryoprobes used to complete cryoablation for a single target lesion during the cryoablation procedure.
Measured: The day of the procedure
Puncture time
Time from when the needle tip enters the skin to the completion of the puncture.
Measured: The day of the procedure
Ablation time
Time for the single lesion from when the cryoprobe arrives at the target to when the investigator judges the cryoablation is completed.
Measured: The day of the procedure
Procedure time
Time from when the patient is positioned to the completion of the ablation procedure as judged by the investigator.
Measured: The day of the procedure
Evaluation of system performance
Subjective evaluation from the radiologists regarding the commonly used functions, operation, stability, and convenience of the research device.
Measured: The day of the procedure
Compliations
Complications including pneumothorax, hemoptysis, bleeding, and other rare complications.
Measured: 7±1 days postoperatively/on the day of discharge (whichever comes first).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan United Imaging Surgical co., ltd.
- Responsible party
- Sponsor
- Investigators
- Wenge Xing, Professor, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581107
- Sponsor's protocol ID
- ZRIR-002-24-06
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validate the Feasibility and Safety of the Robot System by Investgating the CT-fluoroscopy Guidance in Percutaneous Lung Cryablation Procedures of Participants With Lung Cancer
- ClinicalTrials.gov ID
- NCT06581107
- Acronym / sponsor ID
- ZRIR-002-24-06
- Conditions
- Lung Cancer, Thoracic Cancer
- Keywords
- Image-guided Biopsy; Robot-assisted procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Wuhan United Imaging Surgical co., ltd.
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Sep 2024 (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.
This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance.
The main questions this study aims to answer are:
- Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas;
- Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment;
- Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time;
- Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate;
- Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.
Detailed description
Lung cancer is the leading cause of morbidity and mortality of malignant tumors.
The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer (NSCLC), with proven long-term cure rates and survival. However, more than 20% of patients are not eligible for surgical treatment due to comorbidities or poor underlying lung reserve.
With the development of minimally invasive interventional field, lung cancer cryoablation has also become an established tool for the treatment of early stage lung cancer and palliative treatment of advanced lung cancer in recent years.
However, the image-guidance cryoablation method still faces the following challenges:
- Lack of real-time and accurate information during the needle insertion process, including puncture force, needle deformation, soft tissue deformation, and needle arrival position;
- Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area, which leads to prolonged operation time, easily induces complications and increases the radiation dose to the physicians.
- The accuracy of needle insertion is highly affected by the patient's respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs (movement, rotation, etc.), resulting in the drift of the tumour position. Eventually, it is difficult for radiologists to reach the target position, resulting in insufficient ablation areas and increased probability of cancer recurrence.
- The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax
- The procedure is highly dependent on the ability and experience of radiologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singel arm | Experimental | Procedure: CT-fluoroscopy guided master-slave intervetional robot-assisted lung CryoablationCT-fluoroscopy guided robot-assisted percutaneous lung Cryoablation group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures;
- Participants voluntarily participate in this clinical study and sign the informed consent form;
- Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer;
- Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required.
Key exclusion criteria (13 listed)
- Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy;
- Participants suffer from extensive pleural metastases with massive pleural effusion;
- Participants have tumors adjacent to the mediastinal blood vessels, contrast allergy, or inability to cooperate, which makes it difficult to choose the route of needle insertion;
- Participants with lesions encircling blood vessels where ablation may lead to severe bleeding;
- Participants with severely impaired lung function, with maximal ventilation <40%;
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 |
|---|---|---|
| CT-fluoroscopy guided master-slave intervetional robot-assisted lung CryoablationDuring the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first). | Procedure or surgery | Singel arm |
Primary outcome
Technical success rate
Time frame: The day of the procedure
After the cryoablation procedure, the radiologists evaluate the consistency of the postoperative ablation area derived from the immediate postoperative thoracic CT scan with the size of the preoperative planning area. If consistent, it is defined as a technical success. The technical success rate is defined as the ratio of the number of participants with technical success to the total number of enrolled participants.
7 secondary outcomes
The number of needle adjustments
Time frame: The day of the procedure
Number of cryoprobes used
Time frame: The day of the procedure
Puncture time
Time frame: The day of the procedure
Ablation time
Time frame: The day of the procedure
Procedure time
Time frame: The day of the procedure
Evaluation of system performance
Time frame: The day of the procedure
Compliations
Time frame: 7±1 days postoperatively/on the day of discharge (whichever comes first).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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.
Wenge Xing, Professor principal investigator
Tianjin Medical University Cancer Institute and 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 CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation in people with Lung Cancer and Thoracic Cancer, run by Tianjin Medical University Cancer Institute and 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 4 inclusion and 13 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 3 Sep 2024. 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 Haipeng Yu, PhD (0086-22-23340123, jieruke@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: The day of the procedure). 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 3 Sep 2024.