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临床试验/NCT06660121
NCT06660121撤回不适用

Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
30
试验地点
2
主要终点
Volume reduction in cm

研究概览

简要总结

The goal of this observational study is to learn about the effects of Electrochemotherapy (ECT) in patients with Desmoid Fibromatosis. The main question it aims to answer is:

Is ECT effective in reducing the size of the lesion and improving patients' symptomatology?

Patients will be followed with MRI and Quality of Life questionnaires at 3, 6 and 12 months after the intervention.

详细描述

Desmoid fibromatoses are rare and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.

Other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics.

An additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. However, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. In the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our Institute.

Electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of Bleomycin and its toxicity on tumor cells by a factor of up to several thousand.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic Desmoid Fibromatosis and in active phase (documented growth at last follow-up)
  • Patients not eligible for surgery, cryoablation, or embolization
  • Signature of study-specific informed consent.

排除标准

  • Patients with fibromatosis not in active phase, documented clinically and with imaging investigations (MRI, CT)
  • Patients with documented active infection
  • Previous treatment for < 30 days
  • Pregnancy and lactation status
  • Patients of childbearing age without contraceptive use for at least 3 months
  • Presence of metal synthetic media at the site of treatment
  • COPD with FiO2 < 30 mmHg
  • Impaired renal function with eGFR

结局指标

主要结局

Volume reduction in cm

时间窗: 1 year

Change of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.

次要结局

  • Change of pain (VAS score)(1 year)
  • Change in quality of life ( EuroQol-5D questionnaire)(1 year)
  • Feasibility of in vitro viability analysis of biopsy material(1 year)
  • Evaluation of the role of inflammatory cytokines(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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