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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

- Patients > 18 years
- Histological evidence of DTF
- Patients with failure of active surveillance* for their present manifestation
of DTF
- 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
symptoms

Exclusion Criteria

- 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
procedure
- 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, implants, or prosthesis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the trial will be the patient satisfaction rate 12 months<br /><br>after the completion of the MR-HIFU procedure(s). Patient satisfaction is being<br /><br>defined as the number of patients achieving their own personal satisfaction<br /><br>score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include the presence of non-perfused volume on MRI after the<br /><br>MR-HIFU procedure, change in tumour volume, the response rate according to the<br /><br>Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v.1.1) and<br /><br>mRECIST criteria, the number of patients who need a re-intervention, time to<br /><br>(re)growth, duration of tumour response and patient satisfaction, adverse<br /><br>events, change in symptoms, pain scores, and health-related quality of life<br /><br>(HRQoL) in the first 12 months after treatment.</p><br>

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