Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study

Bone Metastases Clinical Trial

— EMBONEMET  

Official title:

Embolizzazione Arteriosa Per il Trattamento Delle Metastasi Ossee: Studio Osservazionale Prospettico

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189079
• Other study ID #: CE AVEC: 313/2023/Oss/IOR
• Status: Recruiting
• Start date: May 10, 2023
• Est. completion date: May 10, 2026

Study information

• Verified date: December 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 10, 2026
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	Volume reduction in cm	Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm.	1 year