Treatment of Desmoid Fibromatosis With Arterial Embolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: embolization therapy.
- Who it may be relevant to
- Registry conditions: Desmoid Fibromatosis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Desmoid Fibromatosis With Arterial Embolization: Retrospective and Prospective Observational Study
Overview
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.
Detailed description
Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. 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. 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.
Doxorubicin is routinely used in the treatment of soft tissue sarcomas and other mesenchymal malignancies. Its use against desmoid fibromatosis is effective but associated with hematologic, gastrointestinal, and cardiac toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing, or life-threatening fibromatoses.
Interventions
- Procedure 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 vascul
Primary outcome measures
- Reduction of pain (VAS score) [Time frame: 1 year]
- Reduction of antalgic therapy (mg) [Time frame: 1 year]
- Volume reduction in cm³ [Time frame: 1 year]
Secondary outcome measures (2)
- Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) [Time frame: 1 year]
- Improvement in quality of life (EORTC QLQ - BM22) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06945887 · CE AVEC: 49/Oss/IOR