Clinical trial · Observational
Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET fused CT-Fluoroscopy guided biopsy | Procedure | — | UNRESOLVED |
| Robotic arm assisted PET/CT guided biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Robotic arm assisted PET/CT guided biopsy
- description
- 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.
- interventionNames
- Procedure: Robotic arm assisted PET/CT guided biopsy
- Procedure: PET fused CT-Fluoroscopy guided biopsy
- label
- PET fused CT-Fluoroscopy guided biopsy
- description
- 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
- interventionNames
- Procedure: Robotic arm assisted PET/CT guided biopsy
- Procedure: PET fused CT-Fluoroscopy guided biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available