NL-OMON23077
Not yet recruiting
Not Applicable
Magnetic Resonance imaging-guided high intensity focused ultrasound for patients with Desmoid-type fibromatosis
MC Utrecht0 sites13 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MC Utrecht
- Enrollment
- 13
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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