Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

Trial Title: Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

NCT ID: NCT06268457

Condition: Desmoid

Conditions: Official terms:
Fibromatosis, Aggressive
Doxorubicin

Conditions: Keywords:
Chemoembolization

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Chemoembolization with Doxorubicin
Description: - 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).
Arm group label: Performed chemoembolization

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.

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. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. 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 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. Doxorubicin contains a protonated amine group which can establish an ionic bond with the sulfonate present on the surface of microbeads of hydrogel, ensuring embolization and elution of the drug. This process allows high concentrations of Doxorubicin in the target tissue and low concentrations in the systemic circulation.

Criteria for eligibility:

Study pop:
Patients affected by desmoid fibromatoses eligible to be treated with chemoembolization with Doxorubicin

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups) - Patients who are not candidates for surgery or cryoablation 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Istituto Ortopedico Rizzoli

Address:
City: Bologna
Zip: 40136
Country: Italy

Status: Recruiting

Contact:
Last name: Giancarlo Facchini, MD

Phone: +39 333 650 0944
Email: giancarlo.facchini@ior.it

Start date: February 20, 2024

Completion date: February 1, 2028

Lead sponsor:
Agency: Istituto Ortopedico Rizzoli
Agency class: Other

Source: Istituto Ortopedico Rizzoli

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06268457