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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.
This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device ZetaMetâ„¢ | Experimental | ZetaMetâ„¢ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMetâ„¢ is only for implantation into the vertebral body. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZetaMetâ„¢ (ZetaFuseâ„¢ Bone Graft) | Combination Product | ZetaMetâ„¢ (ZetaFuseâ„¢ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Skeletal Related Events (SREs) | SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention. | Day 0 up to Day 180 |
| Number of subjects with at least one adverse event (AE) | An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition. | Day 0 up to Day 180 |
| Number of subjects with at least one procedure-related AE | A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure. | Day 0 up to Day 180 |
| Number of subjects with at least one device-related AE | A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device. | Day 0 up to Day 180 |
| Change in SINS assessment at 21 days 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). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Coastal Health Research Institute | Vancouver | British Columbia | V5Z 1M9 | Canada | ||
| McGill University Health Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Day 0 to Day 21 postoperatively |
| Change in SINS assessment at 42 days 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). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability. | Day 0 to Day 42 postoperatively |
| Change in SINS assessment at 84 days 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). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability. | Day 0 to Day 84 postoperatively |
| Change in SINS assessment at 180 days 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). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability. | Day 0 to Day 180 postoperatively |
| Change in Short Form 12v2 (SF-12v2) score 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 is given at baseline and at 180 days postoperatively. | Day 0 to Day 180 postoperatively |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days 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. | Day 0 to Day 21 postoperatively |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days 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. | Day 0 to Day 42 postoperatively |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days 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. | Day 0 to Day 84 postoperatively |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days 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. | Day 0 to Day 180 postoperatively |
| Change in vertebral body defect size measured by CT at 42 days compared to baseline | Vertebral body defect size measured by CT | Day 0 to Day 42 postoperatively |
| Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline | Vertebral body defect size and planar radiographs | Day 0 to Day 42 postoperatively |
| Change in vertebral body defect size measured by CT at 180 days compared to baseline | Vertebral body defect size measured by CT | Day 0 to Day 180 postoperatively |
| Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline | Vertebral body defect size measured by planar radiographs | Day 0 to Day 180 postoperatively |
| Duration of use of postoperative prescription opioid | The average per group duration of intake of opioids in the post-operative setting. | Day 180 postoperatively |
| Daily dose of postoperative prescription opioid use | The average per group dosage of opioids in the post-operative setting. | Day 180 postoperatively |
| Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure | Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia | 30 minutes following the placement of the surgical bandage |
| Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure | Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia | 60 minutes following the placement of the surgical bandage |
| Montreal |
| Quebec |
| H3G1A4 |
| Canada |
| D017437 |
| Skin and Connective Tissue Diseases |