Clinical trial NCT05245630: Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lung Diseases
Adenocarcinoma of Lung
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-02-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: three months
Secondary outcomes:
measure: To compare the radiation exposure and complication in the both arms
timeFrame: three months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Nuclear Medicine, PGIMER
state: Chandīgarh
Study officials:
References: