Electrochemotherapy for Desmoid Tumors (ECT-DESMO)

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Desmoid Fibromatosis

Treatments

Procedure: Electrochemotherapy with bleomycin

Study type

Observational

Funder types

Other

Identifiers

NCT06660121

CE AVEC: 418/2024/Oss/IOR

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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