Electrochemotherapy for Desmoid Tumors
Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study
Istituto Ortopedico Rizzoli
30 participants
Oct 17, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
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.
Locations(1)
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NCT06660121