Actively Recruiting

Age: 18Years +
All Genders
ID06268457

Arterial Chemoembolization with Doxorubicin for Treating Symptomatic Desmoid Fibromatosis: A Prospective Observational Study

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-14

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Desmoid fibromatoses are rare, locally aggressive tumors that arise from mesenchymal tissue. This research focuses on evaluating chemoembolization using Doxorubicin delivered through arterial embolization as a treatment for symptomatic and actively growing desmoid fibromatosis, especially in patients unsuitable for surgery or cryoablation. Current treatment guidelines favor active surveillance for asymptomatic cases and reserve chemotherapy for more severe presentations due to associated systemic risks. The study investigates chemoembolization, a procedure involving selective catheterization of arteries supplying the tumor and injecting hydrogel microspheres loaded with Doxorubicin. This approach aims to deliver high drug concentrations directly to the tumor site while minimizing systemic exposure. The procedure includes diagnostic arteriography to confirm successful embolization by occluding over 90% of the tumor's blood supply. Participants will be monitored over one year to assess outcomes such as tumor volume reduction, pain relief using VAS scores, and decreased need for pain medications. Quality of life improvements will also be evaluated using standardized questionnaires. Safety and procedural success will be tracked through imaging and clinical assessments throughout the study, with the total participation duration spanning one year.

CONDITIONS

Brief Title

Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic and actively growing desmoid fibromatosis confirmed by recent follow-up
  • Patients who are not candidates for surgery or cryoablation
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Life expectancy less than 3 months or severely impaired functional status (ASA 4)
  • Desmoid fibromatosis not in active phase, confirmed clinically and by MRI or CT
  • Blood clotting disorders or low platelet counts
  • Active infections documented at the time of evaluation
  • Patients younger than 18 years old (implied by minimum age criterion but stated here for clarity if applicable)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment event with follow-up assessments up to 1 year

Participants undergo arterial chemoembolization with doxorubicin to target desmoid fibromatosis through selective catheterization and embolization.

1 treatment visit (in-person) and multiple follow-up visits over 1 year

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for tumor volume reduction, pain relief, and quality of life improvements following treatment.

Periodic follow-up visits during 1-year post-treatment

Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy, 40136

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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