ZetaFuse™ Bone Graft for Metastatic Breast Cancer in the Spine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Breast Cancer in the SpineZetaFuse™ Bone Graft - Device
Eligibility
22 - 75
Female
What conditions do you have?
Select

Study Summary

This trial is for patients with cancer that has spread to up to 5 areas, who have a spinal instability score of 3-9, who are having the ZetaFuse bone graft implanted in their spine to help with the tumor.

Eligible Conditions
  • Metastatic Breast Cancer in the Spine

Treatment Effectiveness

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Average daily dose of postoperative prescription opioid use.
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) compared to baseline.
Change in SINS assessment compared to baseline.
Change in vertebral body defect size at 42- and 180-day follow-up visits compared to baseline.
Device Feasibility and Preliminary Effectiveness as measured In Number of Skeletal Related Events (SRE) by 180-day follow-up visit.
Opioids
Safety Evaluation
Short Form 12v2 (SF-12v2) at 180-day follow-up visits compared to baseline

Trial Safety

Trial Design

1 Treatment Group

Investigational Device The ZetaFuse™ Bone Graft
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: ZetaFuse™ Bone Graft · No Placebo Group · N/A

Investigational Device The ZetaFuse™ Bone Graft
Device
Experimental Group · 1 Intervention: ZetaFuse™ Bone Graft · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Zetagen Therapeutics, IncLead Sponsor

Eligibility Criteria

Age 22 - 75 · Female Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 22 and 75 years old.
You have 5 or fewer metastases located at 3 or fewer sites.
A lytic metastatic lesion located in the vertebral body of the spine.
You have a normal spine.\n