Clinical trial · Interventional
Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor
Accuracy, Safety and Diagnostic Outcome of Percutaneous Fluoroscopic vs. CT Guided Transpedicular Core Needle Biopsy for Spinal Infections and Tumors. A Prospective Randomized Trial
- 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)
Spinal biopsy is important to obtain culture and histopathological diagnosis in spine infection and tumors. To date, there is no prospective randomized study comparing both techniques. Therefore, the aim of this prospective randomized trial was to evaluate the accuracy, safety and diagnostic outcome of both these techniques.A prospective randomized trial was performed in 60 patients divided equally into fluoroscopic and CT guided spinal biopsy groups. Transpedicular approach was done with 8G core biopsy needle. Specimens were sent for histopathological examinations and cultures. Diagnosis were made based on biopsy results, clinical criteria and disease progression during 6 months follow up. Radiation expose to patients and doctors were measured with optically stimulated luminescence dosimeters (OSLDs).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Tumor | — | UNRESOLVED | — |
| Spondylodiskitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT guided Spinal Biopsy | Diagnostic Test | — | UNRESOLVED |
| Fluoroscopy Guided Spinal Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fluoroscopy Guided Spinal Biopsy Arm
- description
- Fluoroscopy guided spinal biopsies were done by spine surgeons in the operation theatre using C-Arm fluoroscopy device (OECFluorostar7900Compact - GE®). C-arm image intensifier was positioned until fluoroscopic beam was collinear with the corresponding vertebral body on AP view prior to insertion of biopsy needle
- interventionNames
- Diagnostic Test: Fluoroscopy Guided Spinal Biopsy
- type
- ACTIVE_COMPARATOR
- label
- CT guided Spinal Biopsy Arm
- description
- CT guided spinal biopsies were done by radiologist under guidance of 128-slice CT scanner (SOMATOM Definition AS+, Siemens Medical Solutions USA, Inc.). Preliminary axial CT scanning was done in bone window (window width, WW:2500; window level, WL:500) at the pre-selected levels decided from previous imaging to plan the needle access. Biopsy was then performed under sequential CT-fluoroscopy scan.
- interventionNames
- Diagnostic Test: CT guided Spinal Biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age more than 18; 2. Patients who presented with clinical symptoms and radiological features suggestive of infection or malignancy; 3. MRI reported as probable infection or tumour. Exclusion Criteria: 1. Cervical spine lesion; 2. Significant neurological deficit that required urgent surgery; 3. Partially treated spinal infections; 4. Vascular tumour; 5. Infection over skin puncture site; 6. Pregnancy; 7. Bleeding diathesis; 8. Medically unfit for spinal biopsy.
References
Publications (0)
Data not yet available