RecruitingNCT06268457

Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

Chemioembolizzazione Arteriosa Per il Trattamento Della Fibromatosi Desmoide: Studio Osservazionale Prospettico


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

20 participants

Start Date

Feb 20, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. 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. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)
  • Patients who are not candidates for surgery or cryoablation

Exclusion Criteria4

  • 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

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Interventions

PROCEDUREChemoembolization with Doxorubicin

* Identification of the main vessels afferent to the metastasis 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 with doxorubicin) * 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, Emilia-Romagna, Italy

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