NCT06268457 Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis
| NCT ID | NCT06268457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Desmoid |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-02-20 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.
Eligibility Criteria
Inclusion Criteria: * FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups) * Patients who are not candidates for surgery or cryoablation Exclusion Criteria: * Patients with life expectancy \<3 months or severely impaired status functional status (ASA 4) * Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT) * Patients with coagulation deficiency or plateletopenic disease * Patients with documented active infection
Frequently Asked Questions
Who can join the NCT06268457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Desmoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06268457 currently recruiting?
Yes, NCT06268457 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT06268457 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06268457 clinical trial?
NCT06268457 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 20 participants.