Lung CancerMRNCT05715996
Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
A study testing mixed reality guided localization in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- mixed reality guided localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to Mar 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18years of age;
- There was no distant metastasis in preoperative clinical evaluation;
- The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
- Target lung nodule diameter ≤ 2cm
- The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
- preoperative ECOG physical state score 0/1;
- Volunteer to participate in the study and sign the informed consent form.
Who cannot join
- More than two lung nodules need to be removed at the same time.
- The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
- The patient has uncontrollable mental illness and cannot make subjective assessment.
- After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
- After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
- At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zuodong Song
Shanghai, Shanghai Municipality, 200030
Zuodong Song, szd1990@hotmail.com
About this study
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
- Conditions
- Lung Cancer
- Being tested
- mixed reality guided localization
- Keywords
- mixed reality, Localization, sublobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed reality guided localizationDevice
In this study, MR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique.
| Study group | Role | What they receive |
|---|---|---|
| mixed reality guided localization group | Experimental | Application of mixed reality technique for percutaneous lung nodule localization. Receives: Device: mixed reality guided localization |
| Computerized tomography (CT) guided localization group | No intervention | Computerized tomography (CT) guided percutaneous lung nodule localization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of nodule localization
The deviation between the local quantizer and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
Measured: 30 minutes
Secondary outcomes (4)
Operation duration
Since the start/end point of CT-guided pulmonary nodule localization may be arbitrary and there may be differences between different researchers, the program duration is derived from the CT scanning parameters and calculated as the length of time between the initial scan and the final scan. The hybrid reality guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning
Measured: 30 minutes
Incidence of complications
Including pneumothorax, hemoptysis, circulation changes caused by bleeding, pleural reaction, etc
Measured: 7 days
Radiation exposure dose
The dose length product (DLP) was used to quantify the total radiation received by patients during the localization of pulmonary nodules. In addition, after the scanning process, the DLP value is directly displayed on the screen of the CT scanner. In order to estimate the relative amount of radiation dose, the effective dose (ED) is also calculated according to the DLP value
Measured: 30 minutes
Postoperative puncture pain assessment
On the first day after the operation, when the patient was fully awake, the pain degree of the patient during the positioning process was evaluated by using the NRS (digital scoring method) and the Digital Assessment Scale of Pain Degree. The degree of pain is expressed in 0-10 numbers, 0 means no pain, and 10 means the most severe pain. It is left to the patient to choose a number that best represents the degree of pain, and the medical staff will select the corresponding number according to the patient's description of pain. According to the corresponding number of pain, the pain degree is divided into mild pain (1-3), moderate pain (4-6), and severe pain (7-10)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start23 May 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (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 Shanghai Chest 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
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinghua Cheng, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715996
- Sponsor's protocol ID
- ShanghaiChestMR
- Acronym
- MR
- Status last verified
- Nov 2023
- First submitted
- 27 Jan 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05715996
- Acronym / sponsor ID
- MR / ShanghaiChestMR
- Conditions
- Lung Cancer
- Keywords
- mixed reality, Localization, sublobectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mixed reality guided localization group | Experimental | Device: mixed reality guided localizationApplication of mixed reality technique for percutaneous lung nodule localization. |
| Computerized tomography (CT) guided localization group | No intervention | –Computerized tomography (CT) guided percutaneous lung nodule localization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 18years of age;
- There was no distant metastasis in preoperative clinical evaluation;
- The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
- Target lung nodule diameter ≤ 2cm
- The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
Key exclusion criteria (6 listed)
- More than two lung nodules need to be removed at the same time.
- The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
- The patient has uncontrollable mental illness and cannot make subjective assessment.
- After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
- After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
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 |
|---|---|---|
| mixed reality guided localizationIn this study, MR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique. | Device | mixed reality guided localization group |
Primary outcome
Accuracy of nodule localization
Time frame: 30 minutes
The deviation between the local quantizer and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
4 secondary outcomes
Operation duration
Time frame: 30 minutes
Incidence of complications
Time frame: 7 days
Radiation exposure dose
Time frame: 30 minutes
Postoperative puncture pain assessment
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed reality guided localization in people with Lung Cancer, run by Shanghai Chest 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 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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 Xinghua Cheng, MD (+8617701681215, chengxinghua_001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of nodule localization (time frame: 30 minutes). 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 Nov 2023.