ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body

Study Overview
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Brief Summary
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The ZetaFuse™ Bone Graft is indicated for patients with destructive, lytic lesions due to oligometastatic cancer (≤5 metastatic lesions located at ≤3 tissue 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. The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

Detailed Description
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This is an open-label single-arm study. Subjects (N=10) will be recruited from a single Investigational Site in Canada. Key inclusion criteria are oligometastatic primary breast cancer (≤5 metastatic lesions located at ≤3 tissue sites) with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. The ZetaFuse™ Bone Graft will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.

Official Title
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Feasibility Study of ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body

Conditions
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Metastatic Breast Cancer in the Spine

Intervention / Treatment
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* Device: ZetaFuse™ Bone Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment. Life expectancy of 12 months or more. Female patient with histologically confirmed diagnosis of primary breast cancer. ≤5 metastases located at ≤3 sites (patients with single metastasis qualify) At least one lytic metastatic lesion located in the vertebral body of the spine. Normal spinal alignment. SINS ≥3 and ≤9. Signed and dated Informed Consent Form (ICF). Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires. Exclusion Criteria: Vertebral body collapse. Spinal cord compression. Known allergy to Investigational Device materials. Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids). Current tobacco smoker or stopped smoking in past 6 months. Diagnosis of diabetes. An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC)). Currently participating in any investigational trial not related to this trial. Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial. Pregnant or planning to become pregnant during the trial.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device The ZetaFuse™ Bone Graft<br>The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body. | Device: ZetaFuse™ Bone Graft<br>* The ZetaFuse™ Bone Graft will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Feasibility and Preliminary Effectiveness as measured In Number of Skeletal Related Events (SRE) by 180-day follow-up visit. | SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention. Number of Skeletal Related Events will be evaluated 180-day post operatively. | 6 months | 
| Safety Evaluation | Safety will be characterized by a summary of the incidence of adverse events (AEs), procedure-related AEs, and device-related AEs. | 6 months | 
| Change in SINS assessment compared to baseline. | The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements)7. The SINS ranges from 0-18. Score in range from 0-6 denote stability; 7-12 intermediate instability and 13-18 instability. SINS assessments will be completed during patient screening (repeat at baseline if screening visit is more than 2 weeks prior to the scheduled surgery), 21-days post operatively, 42-days post operatively, 84-days post operatively, and 180-days post operatively. | 6 months | 
| Short Form 12v2 (SF-12v2) at 180-day follow-up visits compared to baseline | The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 will be given at baseline and 180-days post operatively. | 6 months | 
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) compared to baseline. | The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where 0 denotes no pain and 10 is the worst imaginable pain. The SF-12v2 will be given at baseline, 21-, 42-, 84-, and 180-day post operatively. | 6 months | 
| Change in vertebral body defect size at 42- and 180-day follow-up visits compared to baseline. | CT and Planar Radiographs will be given at baseline, 42- and 180-days post operatively. | 6 months | 
| Duration of use of postoperative prescription opioid use. | Use of opioids in the post-operative setting will be evaluated for duration of use. | 6 months | 
| Average daily dose of postoperative prescription opioid use. | Use of opioids in the post-operative setting will be evaluated for dosage. | 6 months |