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

NCT06189079 | Recruiting

• 1 other identifier: CE AVEC: 313/2023/Oss/IOR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Keywords

Arterial embolization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Volume reduction in cm

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent arterial embolization in the treatment of bone metastases

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 3, 2024
• Study Start: May 10, 2023
• Primary Completion: October 10, 2025
• Study Completion (Estimated): May 10, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

IT (1)