NL-OMON23077尚未招募不适用
Magnetic Resonance imaging-guided high intensity focused ultrasound for patients with Desmoid-type fibromatosis
MC Utrecht0 个研究点目标入组 13 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients > 18 years
- •-Histological evidence of DTF
- •-Patients with failure of active surveillance* for their present manifestation of DTF
- •-Desmoid tumor must be targetable with MR-HIFU device
- •-Desmoid tumor must be visible on pre-treatment MR-imaging
- •-Patient is able to fit in the MRI gantry
- •-Capable to understand and sign informed consent
- •*failure of active surveillance due to tumor growth and/or new or worsening symptoms
排除标准
- •-Personal or family history of familial adenomatous polyposis (FAP)
- •-Intra-abdominal tumor localization
- •-Patients with a tumor greater than 10 centimeters
- •-Patients who have undergone prior active treatment (systemic therapy, radiotherapy, prior ablation) for the present manifestation of DTF
- •-Patients with recurrent disease within 12 months after treatment for their prior desmoid tumor
- •-Patients weighing more than 140 kilograms
- •-Pregnancy
- •-Contra indications to MRI, MRI contrast agents or sedation
- •-Unavoidable critical structures or dense tissues in target area*
- •-Any other condition, which in the opinion of the investigators, would put the patient at increased risk or otherwise make the patients unsuitable for this study
- •*as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device, surgical clips
研究者
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