Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Progression of disease using mRECIST 1.1 criteria
研究概览
简要总结
Desmoid tumors (DT) are uncommon tumors that arise from musculoaponeurotic structures. Despite benign, they can cause pain and disability due to their tendency to be locally aggressive. Cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic DT. This involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.Although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Nevertheless, MRI can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. These changes in heterogeneity can be quantified using a radiomics approach. The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to RECIST 1.1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation
- •baseline MRI
- •clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up
排除标准
- •- not meeting inclusion criteria
结局指标
主要结局
Progression of disease using mRECIST 1.1 criteria
时间窗: 6 months
The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation based on quantification of early changes in heterogeneity sign at MRI images and to compare their performance with those of alternative radiologic response criteria for predicting progression according to mRECIST 1.1. Description of mRECIST 1.1 criteria: CR = complete response, disappearing of contrast enhancement of all lesions; PR= partial response, ≥30% dicrease in the sum of the diameters of contrast enhancement of target lesions; SD= stable disease, neither partial response nor progressive disease; PD= progressive disease, ≥20% size increase in contrast enhancement of the target lesions or new disease.
次要结局
未报告次要终点
