At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
FEASIBILITY STUDY OF ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN THE SPINAL VERTEBRAL BODY: A PHASE 2A, MULTICENTER, OPEN-LABELED, SINGLE-ARM STUDY
In Brief
A Phase 2 clinical trial evaluating ZetaMet™ (ZetaFuse™ Bone Graft) for Metastatic Breast Cancer in the Spine. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.
Study Details
Timeline
Interventions
ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.