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临床试验/NCT06224283
NCT06224283招募中不适用

Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年2月20日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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