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NCT Number: NCT06189079

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

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.

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Key information

Conditions

Bone Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location status: Recruiting

Location contact

Giancarlo Facchini, MD

CONTACT

[email protected]

+39 333 650 0944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reduction of pain (VAS score)

    Time frame: 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.

  2. Improvement in quality of life (EORTC QLQ - BM22)

    Time frame: 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.

  3. Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)

    Time frame: 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 outcomes

  1. Volume reduction in cm

    Time frame: 1 year

    Reduction of the lesion evaluated with CT scans, measuring the diameter of the lesion in cm.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: EMBONEMET

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 3, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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