Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Segmentation comparison
研究概览
简要总结
This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.
详细描述
The investigator will inform the child and his parents during the pre-surgical consultation, and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan. Patients requiring emergency imaging will not be included.
Pelvic tumors will benefit from MRI imaging and renal tumors from MRI and/or CT scan.
A CT scan will be carried out for retroperitoneal tumors other than renal tumors (mainly neuroblastomas).
All of the above examinations are carried out as part of the usual treatment, in the month preceding the surgery.
Pre-operatively After the imaging has been carried out, the 2D images will be presented to the patient and his family before surgery as it is done routinely. The 3D image will be showed afterwards. The family will have the opportunity to ask questions which the surgeon will answer as usually done.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 3 months and less than 18 years old
- •Children with a pelvic tumor requiring an MRI for a possible surgical intervention
- •Children with a retroperitoneal tumor requiring a CT scan or MRI with a view to surgical intervention
- •Children with no contraindication for a CT scan and/or 3T MRI
- •Children whose parents do not object to their participation in the study
- •Other participants:
- •Operating surgeon agreeing to participate in the study
- •Caregiver agreeing to participate in the study
- •External surgeon agreeing to participate in the study
排除标准
- •Contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm
- •Need for an MRI under general anaesthesia
- •Contraindication for a CT scan with injection: renal failure, allergy to iodinated contrast products
- •Patients having participated in a therapeutic clinical trial involving a new molecule within 30 days before inclusion
- •Emergency situation
研究组 & 干预措施
Children planned to get an MRI or CT scan
Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention
结局指标
主要结局
Segmentation comparison
时间窗: 1 month
Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
次要结局
- 3D modelling added value evaluation pre-operatively(Day 0)
- Consistency evaluation between 3D modelling and anatomy(1 month)
- Pre-operative planning contribution(Day 0)
- 3D modelling evaluation contribution for families' understanding(Day 0)
- 2D imaging evaluation contribution for families' understanding(Day 0)
- Distance comparison(1 month)
- Anatomical structure recognition comparison(Day 0)
- Added value evaluation(Day 0)
- Surgeons' support evaluation in pre-operative routine(Day 0)
- 3D modelling added value evaluation during surgery(1 month)
- Surgeons' support evaluation in current practice(1 month)