Abdominal CancerNCT06484764
Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Biopsy Procedure.
A study testing CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions and Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions in people with Abdominal Cancer and Thoracic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites in China.
Trial summary
This multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer, Thoracic Cancer
- What is being tested?
- CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions and Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jul 2023to 24 Nov 2023
- 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
- Participants have suspected thoracic or abdomen lesions.
- Participants need to receive CT-guided non-vascular percutaneous biopsy procedure
- Lesion size ≥ 10 mm that confirmed by radiologists through the preoperative CT.
Who cannot join
- Participants with uncorrectable coagulopathy, infectious lesions in the planned needle trajectory path, pulmonary echinococcosis considered on CT imaging, patients who need mechanical ventilation, hepatic alveolar echinococcosis, coma or other diseases that the investigators think not suitable for joining the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
First Clinical Affiliation of Guangzhou Medical University
Guangzhou
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tongji Hospital of Huazhong University of Science and Technology
Wuhan
About this study
Official title: Validate the Feasibility and Safety of the Robot System by Comparing the CT-fluoroscopy Guidance Versus CT-guided Freehand Needle Biopsy in Participants With Suspected Thoracic or Abdominal Lesions in a Randomized Controlled Trial
This multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance. The main questions it aims to answer are:
- Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure.
- Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment
- Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate
- Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion.
Read more
All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group.
Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance.
Participants in the control group will receive a freehand needle biopsy under the CT guidance.
Read the detailed description
Cancer has become the second main death reason among Chinese residents. According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 4.57 million new cases of cancer and more than 3 million deaths in China in 2020, accounting for 23.7% and 30.2% respectively of the total number of global cancer incidence and deaths in 2020. Early detection and early treatment have become crucial to reducing cancer incidence and mortality. Image-guided percutaneous needle biopsy has been an important and established method for tumour treatment and diagnosis. More specifically, physicians under CT, MRI (magnetic resonance imaging) or ultrasound guidance manually insert a puncture needle into the target area of the soft tissue lesion for biopsy. However, the image-guidance freehand biopsy 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 insert the target position, resulting in false negative results of biopsy or procedure failure.
- The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax
- Percutaneous puncture procedure is highly dependent on the ability and experience of radiologists.
Here, the investigators aim to evaluate whether the robot-assisted needle biopsy method can solve these challenges by comparing the safety and feasibility of robotic-assisted percutaneous needle biopsy with freehand needle biopsy.
- Conditions
- Abdominal Cancer, Thoracic Cancer
- Being tested
- CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions, Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions
- Keywords
- Image guided biopsy, Robot-assisted method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesionsProcedure or surgery
During the procedure, the participant first undergoes a CT scan the radiologist plans the needle trajectory based on the registered preoperative CECT (contrast-enhanced computed tomography
) and intraoperative CT. After the participant is manually sterilised and given local anaesthesia, the radiologist will remotely control the robot to finish the needle insertion process under the CT-fluoroscopy guidance and simultaneously adjust the angular needle if necessary. The radiologist confirms whether the needle has reached the target area by CT-fluoroscopy image.
Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesionsProcedure or surgery
Radiologists following the current clinical practice guidance to finish the freehand biopsy procedure under the CT guidance.
| Study group | Role | What they receive |
|---|---|---|
| CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group | Experimental | Remote controlled, CT-fluoroscopy guided, robot-assisted biopsy procedure of thoracic and abdominal lesions Receives: Procedure: CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesions |
| Freehand needle biopsy group under the CT guidance | Active comparator | Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions Receives: Procedure: Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-time puncture success rate
The criteria for successful one-time puncture were as follows: the operator judged that the needle had reached the target area without any needle withdrawal or needle direction change during the puncture time that from the needle tip penetrated the skin to the time that needle reached to the target area.
The one-time puncture success rate = number of participants with one-time puncture success (study group or control group) / total number of subjects in the (study group or control group)*100%
Measured: The same day of the procedure
Secondary outcomes (5)
The number of needle adjustments
The number will be counted when the needle tip angle was altered or needle retreat during puncture procedure.
Measured: The same day of the procedure
Procedure time
Time from the patient was positioned to the arrival at the target area that confirmed by CT imaging.
Measured: The same day of the procedure
Puncture time
Time from the needle tip at the skin entry point to the puncture was completed.
Measured: The same day of the procedure
Radiation exposure dose to the patient
Total radiation dose received by patient during the procedure
Measured: The same day of the procedure
Complication rate
The proportion of patients with complications in the two groups. Complications including pneumothorax, pneumothorax, hemoptysis, bleeding and other adverse events.
Measured: Three days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start3 Jul 2023
- Primary completion3 Oct 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China
- Responsible party
- Principal investigator, Haipeng Yu, Tianjin Medical University Cancer Institute and Hospital
- Investigators
- Yu Haipeng, PhD,MD, Principal investigator, Tianjin Medical University Cancer Institute and HospitalNan Wang, PhD,MD, Principal investigator, Tongji HospitalBin Xiong, MD, PhD, Principal investigator, First Clinical Affiliation of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484764
- Sponsor's protocol ID
- ZRIR-003-22-01
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 5 Jul 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 5 Jul 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 Comparing the CT-fluoroscopy Guidance Versus CT-guided Freehand Needle Biopsy in Participants With Suspected Thoracic or Abdominal Lesions in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06484764
- Acronym / sponsor ID
- ZRIR-003-22-01
- Conditions
- Abdominal Cancer, Thoracic Cancer
- Keywords
- Image guided biopsy, Robot-assisted method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, Wuhan United Imaging Healthcare-Surgical Technology Co., Ltd. Wuhan, China
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 3 Jul 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 multicenter, randomized controlled trial aims to investigate whether the interventional robot can be well and safely used for percutaneous needle biopsy compared with the freehand needle biopsy method under CT guidance in patients with suspected thoracic or abdominal lesions. The robot allows radiologists to remotely control the needle insertion process under the CT-fluoroscopy guidance. The main questions it aims to answer are:
- Whether the robot-assisted needle biopsy method can decrease patient radiation exposure during the biopsy procedure.
- Whether the robot-assisted needle biopsy method can improve the success rate for radiologists to insert the needle into the target lesions area without additional needle adjustment
- Whether the robot-assisted needle biopsy method can decrease the patient's complication occurrence rate
- Whether the robot-assisted needle biopsy method can decrease the time from the beginning to the end of needle insertion.
All the participants with suspected thoracic and abdominal lesions will be randomly assigned to the study group or control group.
Participants in the study group will receive a robot-assisted biopsy procedure under the CT-fluoroscopy guidance.
Participants in the control group will receive a freehand needle biopsy under the CT guidance.
Detailed description
Cancer has become the second main death reason among Chinese residents. According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 4.57 million new cases of cancer and more than 3 million deaths in China in 2020, accounting for 23.7% and 30.2% respectively of the total number of global cancer incidence and deaths in 2020. Early detection and early treatment have become crucial to reducing cancer incidence and mortality. Image-guided percutaneous needle biopsy has been an important and established method for tumour treatment and diagnosis. More specifically, physicians under CT, MRI (magnetic resonance imaging) or ultrasound guidance manually insert a puncture needle into the target area of the soft tissue lesion for biopsy. However, the image-guidance freehand biopsy 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 insert the target position, resulting in false negative results of biopsy or procedure failure.
- The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax
- Percutaneous puncture procedure is highly dependent on the ability and experience of radiologists.
Here, the investigators aim to evaluate whether the robot-assisted needle biopsy method can solve these challenges by comparing the safety and feasibility of robotic-assisted percutaneous needle biopsy with freehand needle biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group | Experimental | Procedure: CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesionsRemote controlled, CT-fluoroscopy guided, robot-assisted biopsy procedure of thoracic and abdominal lesions |
| Freehand needle biopsy group under the CT guidance | Active comparator | Procedure: Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesionsFreehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants have suspected thoracic or abdomen lesions.
- Participants need to receive CT-guided non-vascular percutaneous biopsy procedure
- Lesion size ≥ 10 mm that confirmed by radiologists through the preoperative CT.
Key exclusion criteria (1 listed)
- Participants with uncorrectable coagulopathy, infectious lesions in the planned needle trajectory path, pulmonary echinococcosis considered on CT imaging, patients who need mechanical ventilation, hepatic alveolar echinococcosis, coma or other diseases that the investigators think not suitable for joining 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 |
|---|---|---|
| CT-fluoroscopy guided robot-assisted biopsy of thoracic and abdominal lesionsDuring the procedure, the participant first undergoes a CT scan the radiologist plans the needle trajectory based on the registered preoperative CECT (contrast-enhanced computed tomography ) and intraoperative CT. After the participant is manually sterilised and given local anaesthesia, the radiologist will remotely control the robot to finish the needle insertion process under the CT-fluoroscopy guidance and simultaneously adjust the angular needle if necessary. The radiologist confirms whether the needle has reached the target area by CT-fluoroscopy image. | Procedure or surgery | CT-fluoroscopy guided robot-assisted percutaneous needle biopsy group |
| Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesionsRadiologists following the current clinical practice guidance to finish the freehand biopsy procedure under the CT guidance. | Procedure or surgery | Freehand needle biopsy group under the CT guidance |
Primary outcome
One-time puncture success rate
Time frame: The same day of the procedure
The criteria for successful one-time puncture were as follows: the operator judged that the needle had reached the target area without any needle withdrawal or needle direction change during the puncture time that from the needle tip penetrated the skin to the time that needle reached to the target area. The one-time puncture success rate = number of participants with one-time puncture success (study group or control group) / total number of subjects in the (study group or control group)*100%
5 secondary outcomes
The number of needle adjustments
Time frame: The same day of the procedure
Procedure time
Time frame: The same day of the procedure
Puncture time
Time frame: The same day of the procedure
Radiation exposure dose to the patient
Time frame: The same day of the procedure
Complication rate
Time frame: Three days after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
Yu Haipeng, PhD,MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
Nan Wang, PhD,MD principal investigator
Tongji Hospital
Bin Xiong, MD, PhD principal investigator
First Clinical Affiliation of Guangzhou Medical University
3 sites 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 robot-assisted biopsy of thoracic and abdominal lesions and Freehand CT-guided percutaneous needle biopsy of thoracic and abdominal lesions in people with Abdominal Cancer and Thoracic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites 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 1 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: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
One-time puncture success rate (time frame: The same 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 5 Jul 2024.