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

Recruiting

• Conditions: Bone Metastases

• Registration Number: NCT06189079
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-05-10
• Study Completion: 2026-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life (EORTC QLQ - BM22)	1 year	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.
Reduction of pain (VAS score)	1 year	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.
Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Volume reduction in cm	1 year	Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Emilia Romagna, Italy