Clinical trial · Observational
Electrochemotherapy for Desmoid Tumors
Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties in recruitment.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Desmoid Fibromatosis | Desmoid Fibromatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotherapy with bleomycin | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Performed electrochemotherapy
- description
- Patients diagnosed with desmoid fibromatosis unable to perform or failed other treatments who are treated with electrochemotherapy
- interventionNames
- Procedure: Electrochemotherapy with bleomycin
Primary outcomes (1)
- measure
- Volume reduction in cm
- timeFrame
- 1 year
- description
- Change of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.
Secondary outcomes (4)
- measure
- Change of pain (VAS score)
- timeFrame
- 1 year
- description
- Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available