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Clinical Trials/NL-OMON54042
NL-OMON54042
Recruiting
Not Applicable

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

niversitair Medisch Centrum Utrecht0 sites13 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
aggressive fibromatosis
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
13
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • \- 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

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

Outcomes

Primary Outcomes

Not specified

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