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Идёт набор NCT06945887

Treatment of Desmoid Fibromatosis With Arterial Embolization

— Наблюдательное Desmoid Fibromatosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: embolization therapy.
Кому может быть актуально
Состояния в реестре: Desmoid Fibromatosis. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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

Первичные конечные точки

  • Reduction of pain (VAS score) [Срок оценки: 1 year]
  • Reduction of antalgic therapy (mg) [Срок оценки: 1 year]
  • Volume reduction in cm³ [Срок оценки: 1 year]
Вторичные конечные точки (2)
  • Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) [Срок оценки: 1 year]
  • Improvement in quality of life (EORTC QLQ - BM22) [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

NCT: NCT06945887 · CE AVEC: 49/Oss/IOR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗