Lung CancerNCT04299542
Percutaneous Lung Biopsy Using Cone Beam CT With Virtual Guidance: a Randomized Control Trial
A study testing Percutaneous lung biopsy using conventional MDCT and Percutaneous lung biopsy CBCT in people with Lung Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Percutaneous lung biopsy using conventional MDCT and Percutaneous lung biopsy CBCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 May 2020to 22 Nov 2021
- 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
- Solitary or multiple lung lesions (solid or subsolid nodule, pulmonary infiltrate) ≥1cm
Who cannot join
- Patient <18 years old
- Patient not able to give informed consent
- Uncooperative patient who is unable to hold still or hold their breath for safe biopsy
- Lesions <1cm
- Lesions within 1cm of vital thoracic structures such as the great vessels and the mediastinum
- Peripheral lesions accessible to biopsy with ultrasound guidance
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure.
Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.
Virtual guidance has been developed to improve target visibility and access for these complex cases. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.
Read the detailed description
Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. In this era of personalized medicine where knowledge of specific cellular pathways and molecular characterization relies on obtaining optimal tissue sampling, the critical question is how to obtain a high-quality biopsy tissue sample that could be processed for various pathological assessment from a single, minimally invasive percutaneous image-guided approach.
An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure, including the stochastic effect of radiation, and injuries to structures resulting in pneumothorax, pulmonary hemorrhage, and air embolism, which could all be potentially life threatening. Previous studies have also shown that post-biopsy haemorrhage or pneumothorax requiring chest tubes insertion had worse outcome, increased length of hospital stays, and respiratory failure.
Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy, which requires repeated scanning of the target lesion during the procedure and the interventional radiologist entering and leaving the CT suite after each needle adjustment. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.
Virtual guidance has been developed to improve target visibility and access for these complex cases. This involves image registration where the real-time imaging dataset is matched to a reference dataset, where the position of a device is displayed on the current imaging dataset in real time. Syngo iGuideTM is a novel navigational software which has the potential for accurate needle guidance in percutaneous biopsy. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. An integrated laser crosshair is also projected onto the patient's skin to indicate the entry point and angle of the needle at no additional radiation dose to the patient and staff. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.
- Conditions
- Lung Cancer
- Being tested
- Percutaneous lung biopsy using conventional MDCT, Percutaneous lung biopsy CBCT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous lung biopsy using conventional MDCTProcedure or surgery
Conventional CT biopsy will be performed using a 64 slice CT scanner. A preliminary plain CT is acquired covering the entire target lesion with a skin marker, and the interventional radiologist would decide on the skin puncture site and the needle pathway. A post-procedural CT scan will be made to detect pneumothorax or pulmonary haemorrhage. All images will be archived in the picture achieving and communication system (PACS).
Percutaneous lung biopsy CBCTProcedure or surgery
CBCT guided biopsy will be performed in the angiography suite. A preliminary CBCT (DynaCT) is acquired covering the entire target lesion is first performed. Image data will be displayed and processed using Syngo iGuide system. A potential needle trajectory will be drawn from skin to lesion. Integration of the cross-sectional images and real time fluoroscopy will result in three system positions: one bull's eye view and two progression views. During fluoroscopy, the planned needle trajectory and target will be overlaid on the real time fluoroscopy image. After the needle reaches the target, another CBCT will be performed to confirm needle position. Biopsy using coaxial system and post-procedural CT scans will be performed in similar fashion as the conventional CT group.
| Study group | Role | What they receive |
|---|---|---|
| conventional Multi-detector CT (MDCT) | Active comparator | Percutaneous lung biopsy using MDCT Receives: Procedure: Percutaneous lung biopsy using conventional MDCT |
| cone-beam CT (CBCT) | Active comparator | Percutaneous lung biopsy using CBCT Receives: Procedure: Percutaneous lung biopsy CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of needle repositioning to reach the target
This will be recorded during procedure
Measured: immediately after completion of procedure
Secondary outcomes (3)
procedure time
This will be recorded throughout procedure
Measured: immediately after completion of procedure
radiation dose
This will be recorded throughout procedure
Measured: immediately after completion of procedure
complication
observation during and after procedure
Measured: 1 month after completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start4 May 2020
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
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 Chinese University of Hong KongThe 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon Yu, Professor, Principal investigator, DIIR, CUHK, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299542
- Sponsor's protocol ID
- VIR-19-11
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2020
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Lung Biopsy Using Cone Beam CT With Virtual Guidance: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04299542
- Acronym / sponsor ID
- VIR-19-11
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 6 Mar 2020 (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.
Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure.
Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.
Virtual guidance has been developed to improve target visibility and access for these complex cases. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.
Detailed description
Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. In this era of personalized medicine where knowledge of specific cellular pathways and molecular characterization relies on obtaining optimal tissue sampling, the critical question is how to obtain a high-quality biopsy tissue sample that could be processed for various pathological assessment from a single, minimally invasive percutaneous image-guided approach.
An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure, including the stochastic effect of radiation, and injuries to structures resulting in pneumothorax, pulmonary hemorrhage, and air embolism, which could all be potentially life threatening. Previous studies have also shown that post-biopsy haemorrhage or pneumothorax requiring chest tubes insertion had worse outcome, increased length of hospital stays, and respiratory failure.
Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy, which requires repeated scanning of the target lesion during the procedure and the interventional radiologist entering and leaving the CT suite after each needle adjustment. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods.
Virtual guidance has been developed to improve target visibility and access for these complex cases. This involves image registration where the real-time imaging dataset is matched to a reference dataset, where the position of a device is displayed on the current imaging dataset in real time. Syngo iGuideTM is a novel navigational software which has the potential for accurate needle guidance in percutaneous biopsy. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. An integrated laser crosshair is also projected onto the patient's skin to indicate the entry point and angle of the needle at no additional radiation dose to the patient and staff. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional Multi-detector CT (MDCT) | Active comparator | Procedure: Percutaneous lung biopsy using conventional MDCTPercutaneous lung biopsy using MDCT |
| cone-beam CT (CBCT) | Active comparator | Procedure: Percutaneous lung biopsy CBCTPercutaneous lung biopsy using CBCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Solitary or multiple lung lesions (solid or subsolid nodule, pulmonary infiltrate) ≥1cm
Key exclusion criteria (6 listed)
- Patient <18 years old
- Patient not able to give informed consent
- Uncooperative patient who is unable to hold still or hold their breath for safe biopsy
- Lesions <1cm
- Lesions within 1cm of vital thoracic structures such as the great vessels and the mediastinum
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 |
|---|---|---|
| Percutaneous lung biopsy using conventional MDCTConventional CT biopsy will be performed using a 64 slice CT scanner. A preliminary plain CT is acquired covering the entire target lesion with a skin marker, and the interventional radiologist would decide on the skin puncture site and the needle pathway. A post-procedural CT scan will be made to detect pneumothorax or pulmonary haemorrhage. All images will be archived in the picture achieving and communication system (PACS). | Procedure or surgery | conventional Multi-detector CT (MDCT) |
| Percutaneous lung biopsy CBCTCBCT guided biopsy will be performed in the angiography suite. A preliminary CBCT (DynaCT) is acquired covering the entire target lesion is first performed. Image data will be displayed and processed using Syngo iGuide system. A potential needle trajectory will be drawn from skin to lesion. Integration of the cross-sectional images and real time fluoroscopy will result in three system positions: one bull's eye view and two progression views. During fluoroscopy, the planned needle trajectory and target will be overlaid on the real time fluoroscopy image. After the needle reaches the target, another CBCT will be performed to confirm needle position. Biopsy using coaxial system and post-procedural CT scans will be performed in similar fashion as the conventional CT group. | Procedure or surgery | cone-beam CT (CBCT) |
Primary outcome
The number of needle repositioning to reach the target
Time frame: immediately after completion of procedure
This will be recorded during procedure
3 secondary outcomes
procedure time
Time frame: immediately after completion of procedure
radiation dose
Time frame: immediately after completion of procedure
complication
Time frame: 1 month after completion of 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 21 Oct 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.
Simon Yu, Professor principal investigator
DIIR, CUHK, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous lung biopsy using conventional MDCT and Percutaneous lung biopsy CBCT in people with Lung Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 6 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 21 Oct 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 Hong Kong. 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?
The number of needle repositioning to reach the target (time frame: immediately after completion of 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 21 Oct 2022.