RecruitingNCT06945887

Treatment of Desmoid Fibromatosis With Arterial Embolization

Treatment of Desmoid Fibromatosis With Arterial Embolization: Retrospective and Prospective Observational Study


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

20 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Desmoid fibromatoses are rare and locally aggressive mesenchymal tumors. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. These studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy. Instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.


Eligibility

Min Age: 12 Years

Inclusion Criteria5

  • Patients of both sexes aged ≥ 12 years
  • Fibromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)
  • Patients not eligible for surgery or cryoablation
  • Patients who have had embolization surgery for fibromatosis desmoide from 01/01/2023 to date and all new patients listed for this type of treatment.
  • Signature of informed consent to the study

Exclusion Criteria5

  • Patients with life expectancy <3 months or severely impaired status functional status (ASA 4)
  • Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT)
  • Patients with coagulation deficiency or plateletopenic disease
  • Patients with documented active infection
  • Incompatibility to performing MRI examination.

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Interventions

PROCEDUREembolization therapy

Identification of the main vessels afferent to the tumor to be treated. -Selective and super-selective catheterization of pathological arterial branches, responsible for the blood supply to the neoplasm, through the use of micro-catheters. - Injection of embolizing material (hydrogel microspheres) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

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NCT06945887


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