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Electrochemotherapy for Desmoid Tumors

RECRUITINGSponsored by Istituto Ortopedico Rizzoli
Actively Recruiting
SponsorIstituto Ortopedico Rizzoli
Started2024-10-17
Est. completion2028-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06660121

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerDesmoid Fibromatosis

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