Desmoid FibromatosisECT-DESMONCT06660121
Electrochemotherapy for Desmoid Tumors
An observational study of Desmoid Fibromatosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid Fibromatosis
- What is being tested?
- Electrochemotherapy with bleomycin
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of desmoid fibromatosis with an indication for electrochemotherapy treatment
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study
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.
Read the detailed description
Desmoid fibromatoses are rare and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.
Other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics.
An additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. However, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. In the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our Institute.
Electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of Bleomycin and its toxicity on tumor cells by a factor of up to several thousand.
- Conditions
- Desmoid Fibromatosis
- Being tested
- Electrochemotherapy with bleomycin
- Keywords
- Interventional radiology, Electrochemotherapy, Desmoid tumor
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrochemotherapy with bleomycinProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Performed electrochemotherapy | Patients diagnosed with desmoid fibromatosis unable to perform or failed other treatments who are treated with electrochemotherapy Receives: Procedure: Electrochemotherapy with bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction in cm
Change of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.
Measured: 1 year
Secondary outcomes (4)
Change of pain (VAS score)
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.
Measured: 1 year
Change in quality of life ( EuroQol-5D questionnaire)
Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0.
The minimum value represents the worst possible health condition. The maximum value of 1.0 represents the best possible health condition. A value of 1.0 indicates that the patient has no problem in any of the five dimensions assessed by the questionnaire.
Measured: 1 year
Feasibility of in vitro viability analysis of biopsy material
Evaluation of the feasibility of in vitro viability analysis of biopsy material for culturing explants and stabilizing primary cultures. Success is defined as the establishment of primary culture in 70% of samples.
Because desmoid tumors are not aggressive, it may not be easy to maintain them in culture in vitro.
Measured: 1 year
Evaluation of the role of inflammatory cytokines
Evaluation of the prognostic or predictive role of inflammatory cytokines detected in the blood of patients collected on the day of treatment and after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start17 Oct 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Difficulties in recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid FibromatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giancarlo Facchini, Medicine and Surgery, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660121
- Sponsor's protocol ID
- CE AVEC: 418/2024/Oss/IOR
- Acronym
- ECT-DESMO
- Status last verified
- May 2026
- First submitted
- 24 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concerns
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Desmoid Fibromatosis With Electrochemotherapy. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06660121
- Acronym / sponsor ID
- ECT-DESMO / CE AVEC: 418/2024/Oss/IOR
- Conditions
- Desmoid Fibromatosis
- Keywords
- Interventional radiology, Electrochemotherapy, Desmoid tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulties in recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Desmoid fibromatoses are rare and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.
Other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics.
An additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. However, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. In the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our Institute.
Electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of Bleomycin and its toxicity on tumor cells by a factor of up to several thousand.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performed electrochemotherapy | – | Procedure: Electrochemotherapy with bleomycinPatients diagnosed with desmoid fibromatosis unable to perform or failed other treatments who are treated with electrochemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of desmoid fibromatosis with an indication for electrochemotherapy treatment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrochemotherapy with bleomycinElectrochemotherapy (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. | Procedure or surgery | Performed electrochemotherapy |
Primary outcome
Volume reduction in cm
Time frame: 1 year
Change of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.
4 secondary outcomes
Change of pain (VAS score)
Time frame: 1 year
Change in quality of life ( EuroQol-5D questionnaire)
Time frame: 1 year
Feasibility of in vitro viability analysis of biopsy material
Time frame: 1 year
Evaluation of the role of inflammatory cytokines
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Privacy concerns
Related trials for Desmoid Fibromatosis
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A Study in Adults With Desmoid Tumors
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Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Desmoid Tumor, Aggressive Fibromatosis
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Active, not recruitingPhase 2
A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery
Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis
Enrolling by invitationObservational study
Patient-reported Outcomes Following Percutaneous Ablation of Desmoid Tumors
Desmoid Tumor, Aggressive Fibromatoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Facchini, Medicine and Surgery principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Desmoid Fibromatosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume reduction in cm (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.