Treatment of Desmoid Fibromatosis With Arterial Embolization

Condition(s) studied

Investigational drug(s) / intervention(s)

embolization 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).

Study 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

Primary outcome measure(s)

• Reduction of pain (VAS score) — 1 year
  Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
• Reduction of antalgic therapy (mg) — 1 year
  Mean reduction in the use of pain medications evaluated in mg of active ingredient taken daily before the treatment and at follow-up.
• Volume reduction in cm³ — 1 year
  Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm³.

Trial sites (1)

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