Lung CancerNCT05245630
Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy
An observational study of Lung Cancer and Lung Diseases, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lung Diseases, Adenocarcinoma of Lung
- What is being tested?
- Robotic arm assisted PET/CT guided biopsy and PET fused CT-Fluoroscopy guided biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2020to 31 Jan 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants attending the pulmonary medicine department with clinical suspicion of lung lesions were referred to the Department of Nuclear Medicine for lung biopsies were recruited for the study. The participants were randomly assigned to either of the two intervention arms. Baseline heart rate, blood pressure, oxygen saturation and respiratory system examination were done for all the participants included in the study.
Who may be able to join
- Age >/= 18 years
- FDG avid amenable lung lesion
- INR < 1.2 and Platelet counts > 80,000/mm3
Who cannot join
- Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2 and Platelet counts ≤ 80,000/mm3
- Participants who refuse to provide the written informed consent
- Signs of hypoperfusion like cyanosis, hypotension etc.
- Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)
- Pregnant/Lactating females participants
- Non-cooperative participants
- Inaccessible lesions (based on the decision made on pre-biopsy planning)
- CoVID-19 positive participants
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Nuclear Medicine, PGIMER
Chandigarh, Chandigarh, 160012
About this study
Official title: Comparison of Real-time Robotic Arm-assisted 18F-FDG PET/CT-guided Lung Biopsy Versus PET Fused CT- Fluoroscopy-guided Lung Biopsy: a Randomized Trial to Assess Diagnostic Performance and Patient Safety.
Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
Read the detailed description
Patients with clinical suspicion of lung lesions were recruited for FDG PET/CT. Based on the PET/CT findings and clinical details a PET/CT guided biopsy was planned. The patients were assigned to the two arms. In the first arm, participants underwent a robotic-assisted biopsy. In the second arm, participants underwent PET/CT-directed CT fluoroscopy-guided lung biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
- Conditions
- Lung Cancer, Lung Diseases, Adenocarcinoma of Lung
- Being tested
- Robotic arm assisted PET/CT guided biopsy, PET fused CT-Fluoroscopy guided biopsy
- Medical subject headings
- Lung Neoplasms, Lung Diseases, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic arm assisted PET/CT guided biopsyProcedure or surgery
After preparing the participant for the procedure, the participant was positioned on the PET/CT table with the immobilizer.
An automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) was used to guide the needle for biopsy.
Co-axial 18 G biopsy needle (BARD Biopsy disposable coaxial biopsy needle pack, Bard Peripheral Vascular, Inc., Arizona, USA) was inserted according to the orientation planned by the robotic biopsy device.
After the location is ensured, the trocar stylet is removed from the coaxial cannula and specimens were retrieved using a semiautomated biopsy gun.
A repeat CT chest was acquired two hours after the procedure to rule out post-procedural complications.
Complications during the procedure were noted, and immediate management was done.
PET fused CT-Fluoroscopy guided biopsyProcedure or surgery
CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion
| Study group | Role | What they receive |
|---|---|---|
| Robotic arm assisted PET/CT guided biopsy | In this group, participants were recruited for robotic-assisted PET/CT guided biopsy from the FDG avid lung lesions.
biopsies were done using an automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) to guide the needle for biopsy. It is a robotic arm with a four-ax guide arm and a planning console. Pre-interventional fused PET/CT images from Biograph mCT 16 scanner were sent via LAN cable to the device (MAXIO-EX) console. Receives: Procedure: Robotic arm assisted PET/CT guided biopsy; Procedure: PET fused CT-Fluoroscopy guided biopsy | |
| PET fused CT-Fluoroscopy guided biopsy | In this group, participants were recruited for PET fused CT-Fluoroscopy guided biopsy from the FDG avid lung lesions.
A biopsy needle was placed to the target lesion on PET/CT under CT fluoroscopy Receives: Procedure: Robotic arm assisted PET/CT guided biopsy; Procedure: PET fused CT-Fluoroscopy guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy
Histology reports of the biopsies were recorded and the mutation analysis,
Adequacy of the sample was decided by the pathologist who received the sample and when inadequate, we were notified accordingly by the Department of Pathology.
The histopathological results were analyzed. True positive, True negative False-positive and False-negative were calculated for both the groups.
The diagnostic accuracy in percentage for both arms will be calculated and compared.
Measured: three months
Secondary outcomes (1)
To compare the radiation exposure and complication in the both arms
Procedure related complications and radiation exposure to the participants and interventionist were noted in the both arms.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245630
- Sponsor's protocol ID
- NK/6832/MD/594
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data generated or analyzed during the study are available from the primary investigator on a valuable and genuine request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Real-time Robotic Arm-assisted 18F-FDG PET/CT-guided Lung Biopsy Versus PET Fused CT- Fluoroscopy-guided Lung Biopsy: a Randomized Trial to Assess Diagnostic Performance and Patient Safety.
- ClinicalTrials.gov ID
- NCT05245630
- Acronym / sponsor ID
- NK/6832/MD/594
- Conditions
- Lung Cancer, Lung Diseases, Adenocarcinoma of Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Feb 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.
Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
Detailed description
Patients with clinical suspicion of lung lesions were recruited for FDG PET/CT. Based on the PET/CT findings and clinical details a PET/CT guided biopsy was planned. The patients were assigned to the two arms. In the first arm, participants underwent a robotic-assisted biopsy. In the second arm, participants underwent PET/CT-directed CT fluoroscopy-guided lung biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic arm assisted PET/CT guided biopsy | – | Procedure: Robotic arm assisted PET/CT guided biopsy, Procedure: PET fused CT-Fluoroscopy guided biopsyIn this group, participants were recruited for robotic-assisted PET/CT guided biopsy from the FDG avid lung lesions. biopsies were done using an automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) to guide the needle for biopsy. It is a robotic arm with a four-ax guide arm and a planning console. Pre-interventional fused PET/CT images from Biograph mCT 16 scanner were sent via LAN cable to the device (MAXIO-EX) console. |
| PET fused CT-Fluoroscopy guided biopsy | – | Procedure: Robotic arm assisted PET/CT guided biopsy, Procedure: PET fused CT-Fluoroscopy guided biopsyIn this group, participants were recruited for PET fused CT-Fluoroscopy guided biopsy from the FDG avid lung lesions. A biopsy needle was placed to the target lesion on PET/CT under CT fluoroscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants attending the pulmonary medicine department with clinical suspicion of lung lesions were referred to the Department of Nuclear Medicine for lung biopsies were recruited for the study. The participants were randomly assigned to either of the two intervention arms. Baseline heart rate, blood pressure, oxygen saturation and respiratory system examination were done for all the participants included in the study.
Key inclusion criteria (3 listed)
- Age >/= 18 years
- FDG avid amenable lung lesion
- INR < 1.2 and Platelet counts > 80,000/mm3
Key exclusion criteria (8 listed)
- Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2 and Platelet counts ≤ 80,000/mm3
- Participants who refuse to provide the written informed consent
- Signs of hypoperfusion like cyanosis, hypotension etc.
- Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)
- Pregnant/Lactating females participants
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 |
|---|---|---|
| Robotic arm assisted PET/CT guided biopsyAfter preparing the participant for the procedure, the participant was positioned on the PET/CT table with the immobilizer. An automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) was used to guide the needle for biopsy. Co-axial 18 G biopsy needle (BARD Biopsy disposable coaxial biopsy needle pack, Bard Peripheral Vascular, Inc., Arizona, USA) was inserted according to the orientation planned by the robotic biopsy device. After the location is ensured, the trocar stylet is removed from the coaxial cannula and specimens were retrieved using a semiautomated biopsy gun. A repeat CT chest was acquired two hours after the procedure to rule out post-procedural complications. Complications during the procedure were noted, and immediate management was done. | Procedure or surgery | PET fused CT-Fluoroscopy guided biopsy, Robotic arm assisted PET/CT guided biopsy |
| PET fused CT-Fluoroscopy guided biopsyCT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion | Procedure or surgery | PET fused CT-Fluoroscopy guided biopsy, Robotic arm assisted PET/CT guided biopsy |
Primary outcome
To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy
Time frame: three months
Histology reports of the biopsies were recorded and the mutation analysis, Adequacy of the sample was decided by the pathologist who received the sample and when inadequate, we were notified accordingly by the Department of Pathology. The histopathological results were analyzed. True positive, True negative False-positive and False-negative were calculated for both the groups. The diagnostic accuracy in percentage for both arms will be calculated and compared.
1 secondary outcome
To compare the radiation exposure and complication in the both arms
Time frame: three months
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 18 Feb 2022.
- Individual participant dataSharing planned: No. Data generated or analyzed during the study are available from the primary investigator on a valuable and genuine request.
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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?
An observational study of Lung Cancer and Lung Diseases, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 8 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 18 Feb 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 India. 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?
To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy (time frame: three months). 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 18 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.