Electrochemotherapy for Desmoid Tumors

NCT06660121 | Recruiting

• 1 other identifier: CE AVEC: 418/2024/Oss/IOR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Desmoid Fibromatosis

Keywords

Interventional radiology; Electrochemotherapy; Desmoid tumor

Outcome Measures

Primary Outcomes (1)

• Volume reduction in cm

  Change of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.

  1 year

Secondary Outcomes (4)

• Change of pain (VAS score)

  1 year

• Change in quality of life ( EuroQol-5D questionnaire)

  1 year

• Feasibility of in vitro viability analysis of biopsy material

  1 year

• Evaluation of the role of inflammatory cytokines

  3 months

Study Arms (1)

Performed electrochemotherapy

Patients diagnosed with desmoid fibromatosis unable to perform or failed other treatments who are treated with electrochemotherapy

Procedure: Electrochemotherapy with bleomycin

Interventions

Electrochemotherapy with bleomycin PROCEDURE

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.

Performed electrochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of desmoid fibromatosis with an indication for electrochemotherapy treatment

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bioptic material

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Electrochemotherapy; Bleomycin

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Giancarlo Facchini, Medicine and Surgery

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Facchini, Medicine and Surgery

CONTACT

+39 0516366836; giancarlo.facchini@ior.it

Michela Carta, Biotechnology

CONTACT

+39 0516366376; michela.carta@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)