Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy

Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245630
• Other study ID #: NK/6832/MD/594
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age >/= 18 years

2. FDG avid amenable lung lesion

3. INR < 1.2 and Platelet counts > 80,000/mm3

Exclusion Criteria:

1. Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR = 1.2 and Platelet counts = 80,000/mm3

2. Participants who refuse to provide the written informed consent

3. Signs of hypoperfusion like cyanosis, hypotension etc.

4. Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)

5. Pregnant/Lactating females participants

6. Non-cooperative participants

7. Inaccessible lesions (based on the decision made on pre-biopsy planning)

8. CoVID-19 positive participants

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Cancer
• Lung Diseases

Intervention

Procedure:
• Robotic arm assisted PET/CT guided biopsy
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 biopsy
CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion

Locations

Country	Name	City	State
India	Department of Nuclear Medicine, PGIMER	Chandigarh	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three months
Secondary	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.	three months