Using electrochemotherapy to treat desmoid tumors
Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study
This study is testing if electrochemotherapy can help shrink desmoid tumors and improve the quality of life for patients who can't have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06660121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of electrochemotherapy (ECT) in reducing the size of desmoid tumors and improving the quality of life for affected patients. Participants will undergo ECT with bleomycin and will be monitored through MRI scans and quality of life questionnaires at 3, 6, and 12 months post-treatment. The study focuses on patients with symptomatic desmoid fibromatosis who are not candidates for surgery or other minimally invasive treatments. By assessing the outcomes, the study seeks to provide insights into a potentially effective treatment option for this rare condition.
Who should consider this trial
Good fit: Ideal candidates include patients with symptomatic desmoid fibromatosis in an active phase who are not eligible for surgery, cryoablation, or embolization.
Not a fit: Patients with desmoid fibromatosis not in an active phase or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients with desmoid tumors who currently have limited treatment choices.
How similar studies have performed: While electrochemotherapy has shown effectiveness in other soft tissue and bone tumors, its application for desmoid tumors is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Giancarlo Facchini, Medicine and Surgery — IRCCS Istituto Ortopedico Rizzoli
- Study coordinator: Giancarlo Facchini, Medicine and Surgery
- Email: giancarlo.facchini@ior.it
- Phone: +39 0516366836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.