Electrochemotherapy for Desmoid Tumors

NCT ID: NCT06660121

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2029-08-01

Brief Summary

The goal of this observational study is to learn about the effects of Electrochemotherapy (ECT) in patients with Desmoid Fibromatosis. The main question it aims to answer is:

Is ECT effective in reducing the size of the lesion and improving patients' symptomatology?

Patients will be followed with MRI and Quality of Life questionnaires at 3, 6 and 12 months after the intervention.

Detailed Description

Desmoid fibromatoses are rare 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.

Other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics.

An additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. However, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. In the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our Institute.

Electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of Bleomycin and its toxicity on tumor cells by a factor of up to several thousand.

Conditions

Desmoid Fibromatosis

Keywords

Interventional radiology; Electrochemotherapy; Desmoid tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Performed electrochemotherapy

Patients diagnosed with desmoid fibromatosis unable to perform or failed other treatments who are treated with electrochemotherapy

Electrochemotherapy with bleomycin

Intervention Type: PROCEDURE

Electrochemotherapy (ECT) with bleomycin is a localized treatment approach used for managing desmoid fibromatosis, a benign but locally aggressive tumor. This technique combines electrical pulses with the administration of bleomycin, a chemotherapeutic agent, to enhance drug uptake into tumor cells. The electrical pulses create temporary pores in the cell membranes, allowing bleomycin to enter more effectively, leading to increased cytotoxicity. ECT is typically performed on patients who have not responded to conventional therapies or for whom surgery is not feasible. ECT can lead to significant tumor shrinkage and improvement in symptoms, making it a promising option in the multidisciplinary management of desmoid fibromatosis.

Interventions

Electrochemotherapy with bleomycin

Electrochemotherapy (ECT) with bleomycin is a localized treatment approach used for managing desmoid fibromatosis, a benign but locally aggressive tumor. This technique combines electrical pulses with the administration of bleomycin, a chemotherapeutic agent, to enhance drug uptake into tumor cells. The electrical pulses create temporary pores in the cell membranes, allowing bleomycin to enter more effectively, leading to increased cytotoxicity. ECT is typically performed on patients who have not responded to conventional therapies or for whom surgery is not feasible. ECT can lead to significant tumor shrinkage and improvement in symptoms, making it a promising option in the multidisciplinary management of desmoid fibromatosis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Symptomatic Desmoid Fibromatosis and in active phase (documented growth at last follow-up)
• Patients not eligible for surgery, cryoablation, or embolization
• Signature of study-specific informed consent.

Exclusion Criteria

• Patients with fibromatosis not in active phase, documented clinically and with imaging investigations (MRI, CT)
• Patients with documented active infection
• Previous treatment for < 30 days
• Pregnancy and lactation status
• Patients of childbearing age without contraceptive use for at least 3 months
• Presence of metal synthetic media at the site of treatment
• COPD with FiO2 < 30 mmHg
• Impaired renal function with eGFR

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giancarlo Facchini, Medicine and Surgery

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Rizzoli

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giancarlo Facchini, Medicine and Surgery

Role: CONTACT

Phone: +39 0516366836

Email: giancarlo.facchini@ior.it

Michela Carta, Biotechnology

Role: CONTACT

Phone: +39 0516366376

Email: michela.carta@ior.it

Facility Contacts

Giancarlo Facchini, Medicine and Surgery

Role: primary

Michela Carta, Biotechnology

Role: backup

Other Identifiers

CE AVEC: 418/2024/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id