Skip to main content
Clinical Trials/NL-OMON23077
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
MC Utrecht

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

Similar Trials