Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Embolizzazione Arteriosa Per il Trattamento Delle Metastasi Ossee: Studio Osservazionale Prospettico
Overview
To date, arterial embolization constitutes one of the most popular methods in minimally invasive treatment of bone metastases, allowing good results in terms of pain reduction, local control of disease and reduction of peri-operative bleeding, with low invasiveness.
Primary outcome measures
- Reduction of pain (VAS score) [Time frame: 1 year]
- Improvement in quality of life (EORTC QLQ - BM22) [Time frame: 1 year]
- Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) [Time frame: 1 year]
Secondary outcome measures (1)
- Volume reduction in cm [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients of either sex of age or older who are candidates for embolization therapy
- Life expectancy > 3 months
- Single metastatic or oligometastatic.
- Plurimetastatic if a particular site is causing painful symptoms or at risk for pathologic rupture
Exclusion criteria
- Patients with life expectancy <3 months or severe functional status impairment (ASA 4)
- Patients with hypovascular metastasis documented by angiography or MRI perfusion study with MDC.
- Patients with coagulation deficiency or plateletopenic patients.
- Patients with documented active infection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06189079 · CE AVEC: 313/2023/Oss/IOR