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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Metastases

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40136
      • Recruiting
      • Istituto Ortopedico Rizzoli
      • Contact: Giancarlo Facchini, MD; Phone Number: +39 333 650 0944; Email: giancarlo.facchini@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent arterial embolization in the treatment of bone metastases

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume reduction in cm	Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm.	1 year

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): May 10, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Arterial embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: CE AVEC: 313/2023/Oss/IOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No