Health TrialsbyHealthPanel

Treatment of Desmoid Fibromatosis With Arterial Embolization

ConditionDesmoid Fibromatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorIstituto Ortopedico Rizzoli

About this trial

Desmoid fibromatoses are rare and locally aggressive mesenchymal tumors. 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. These studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy.

Instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of both sexes aged ≥ 12 years

Fibromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)

Patients not eligible for surgery or cryoablation

Patients who have had embolization surgery for fibromatosis desmoide from 01/01/2023 to date and all new patients listed for this type of treatment.

Disqualifiers

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

Trial population

Patients affected by desmoid fibromatoses eligible to be treated with transarterial embolization

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • embolization therapy

    Procedure/Surgery

    Identification of the main vessels afferent to the tumor to be treated. -Selective and super-selective catheterization of pathological arterial branches, responsible for the blood supply to the neoplasm, through the use of micro-catheters. - Injection of embolizing material (hydrogel microspheres) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Performed embolization1 intervention

Trial outcomes

Primary outcomes

1

Reduction 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.

Time frame
1 year
2

Reduction of antalgic therapy (mg)

Mean reduction in the use of pain medications evaluated in mg of active ingredient taken daily before the treatment and at follow-up.

Time frame
1 year
3

Volume reduction in cm³

Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm³.

Time frame
1 year

Secondary outcomes

1

Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)

Clinical assessment regarding quality of life by EORTC QLQ-C15-PAL questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology).

Time frame
1 year
2

Improvement in quality of life (EORTC QLQ - BM22)

Clinical assessment regarding quality of life by EORTC QLQ - BM22 questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Source ClinicalTrials.gov
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