Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study
ConditionBone Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients who underwent arterial embolization in the treatment of bone metastases
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
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 year2
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 year3
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). The overall assessment requires a detailed analysis of individual scores and related scales.
Time frame
1 yearSecondary outcomes
1
Volume reduction in cm
Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov