A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases

Launched by BUDA HEALTH CENTER · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and predicting the risk of vertebral fractures in patients who have cancer that has spread to their spine, known as vertebral metastases. Fractures in the spine can significantly affect a person's quality of life and overall health. The researchers are developing new tools, called METASTRA-AI and METASTRA-VPH, that aim to better assess each patient's individual risk of experiencing a fracture within the next six months. By collecting and analyzing data from at least 200 patients, the study hopes to validate these tools and improve how doctors can predict and manage fracture risks in their patients.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with a metastatic tumor in the thoracic or lumbar spine. They should have at least one vertebra that is potentially unstable and have not had surgery to stabilize it. Additionally, participants should be willing to follow up for six months and provide informed consent to participate. Throughout the study, participants can expect to help researchers gather important data that could lead to better care for future patients facing similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient 18 years or older
• • Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)
• • Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)
• • Adjacent vertebrae are not surgically stabilized at the time of the enrollment
• • Patient willing to complete 6-month follow-up
• * Patient is willing and able to provide written informed consent after the nature of the study has been explained:
• • Ability to understand the content of the patient information/ ICF
• • Willingness and ability to participate in the study according to the protocol
• • Signed and dated EC approved written informed consent
• Exclusion Criteria:
• • Poor general status at baseline (Karnofsky scale less than 40%)
• • Expected life expectancy is less than 3 months at baseline
• • Spinal infection
• • Ongoing litigation
• • Participation in investigational clinical study at the same time or within 3 months
• • Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)