At a glance
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Single-site Single-arm Feasibility Study of Patient-specific Interactive 3D Anatomical Models Aimed at Improving Surgery Planning Processes for Complex Renal Cancer Patients
In Brief
An observational study evaluating 3D-models for Kidney Neoplasms and Surgical Oncology. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study aims to determine the feasibility of undertaking a future definitive RCT to evaluate the clinical effectiveness of complementing existing medical scans with a patient-specific interactive 3D virtual model of the patient's body to assist the surgeon with planning for the operation in the best way possible. Renal cancer patients receive a tri-phasic CT scan as routine practice, thus if the standard imaging protocols are followed, there should be ample imaging data available for 3D model creation. This study is a single-site, single-arm, unblinded, prospective, feasibility study aiming to recruit 24 participants from the Royal Free Hospital that are scheduled for robotic-assisted partial nephrectomy. Consenting participants will be recruited over a 6-month period, and interactive 3D virtual models of their anatomy will be generated. These models will be used to aid surgeon-patient communications and to plan for the operation. This study will determine whether a definitive RCT of virtual 3D models as an adjunct to surgery planning is feasible with respect to: recruitment of local authorities and patients; ensuring staff can be adequately trained to deliver programmes within specified timeframes; and assessment of the measurability of key surgical outcomes.
Study Details
Timeline
Interventions
The study radiologist will generate a patient-specific virtual 3D model of the participant's body from their pre-operational medical scans (CT, and MRI if available) using regulated commercial medical image analysis software, specifically Osirix MD 9.0 (Pixmeo, Geneva, Switzerland).(Rosset et al. 2004) The CRFw checks that the medical scan segmentation is accurate and validates the virtual 3D model. The surgeon checks that the medical scan segmentation is accurate and validates the virtual 3D model. The surgeon uses all available medical scan data, and the virtual 3D model as an adjunct, to assess the patient anatomy and plan the operation accordingly