Magnetic Resonance imaging-guided high intensity focused ultrasound for patients with Desmoid-type fibromatosis - MAGNIFIED trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- Patients > 18 years
•- Histological evidence of DTF
•- Patients with failure of active surveillance* for their present manifestation
•- Desmoid tumour must be targetable with MR-HIFU device
•- Desmoid tumour 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

•- Personal or family history of familial adenomatous polyposis (FAP)
•- Intra-abdominal tumour localization
•- Patients with a tumour greater than 10 centimetres (as measured on MRI by a
•radiologist)
•- 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 tumour
•- 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*
•- Inability to tolerate stationary position for the duration of the
•- 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
•*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, implants, or prosthesis

发起方

niversitair Medisch Centrum Utrecht