WithdrawnNot Applicable

Electrochemotherapy for Desmoid Tumors

Stopped: Difficulties in recruitment.

Italy0Started 2024-10-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Volume reduction in cm

Timeframe: 1 year

Trial details

NCT IDNCT06660121

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Desmoid Fibromatosis trials