Magnetic Resonance imaging-guided high intensity focused ultrasound for patients with Desmoid-type fibromatosis
- Conditions
- Desmoid-type fibromatosis
- Registration Number
- NL-OMON23077
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of efficacy:<br>MR-HIFU will be considered as an effective treatment modality for DTF patients if a success is observed in >3 of the 13 patients. If a success is observed in =3 of the 13 DTF patients, it is concluded that MR-HIFU is not an effective treatment strategy in these patients, and should not be further investigated. Otherwise, this study will conclude that this treatment strategy is effective and sufficiently promising, and warrants further investigation in this patient population. The primary outcome will be presented in absolute numbers and proportions.
- Secondary Outcome Measures
Name Time Method