Metastatic Breast Cancer in the Spine
Conditions
Keywords
Metastatic Breast Cancer, Bone Metastases, Spine Metastases, Vancouver, Metastatic Breast Cancer to Bone, X-radiation therapy
Brief 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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTZetaMet™ (ZetaFuse™ Bone Graft)
ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.
Sponsors
Zetagen Therapeutics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 75 Years
Healthy volunteers
No
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. * Metastatic breast cancer to bone, with or without involvement of other 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. * Uncontrolled diabetes mellitus, HbAIC cutoff. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SINS assessment at 180 days compared to baseline | Day 0 to Day 180 postoperatively | 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. |
| Number of Skeletal Related Events (SREs) | Day 0 up to Day 180 | SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention. |
| Number of subjects with at least one adverse event (AE) | Day 0 up to Day 180 | 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. |
| Number of subjects with at least one procedure-related AE | Day 0 up to Day 180 | 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. |
| Number of subjects with at least one device-related AE | Day 0 up to Day 180 | 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. |
| Change in SINS assessment at 21 days compared to baseline | Day 0 to Day 21 postoperatively | 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. |
| Change in SINS assessment at 42 days compared to baseline | Day 0 to Day 42 postoperatively | 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. |
| Change in SINS assessment at 84 days compared to baseline | Day 0 to Day 84 postoperatively | 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. |
| Change in Short Form 12v2 (SF-12v2) score compared to baseline | Day 0 to Day 180 postoperatively | 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. |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline | Day 0 to Day 21 postoperatively | 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. |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline | Day 0 to Day 42 postoperatively | 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. |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline | Day 0 to Day 84 postoperatively | 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. |
| Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline | Day 0 to Day 180 postoperatively | 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. |
| Change in vertebral body defect size measured by CT at 42 days compared to baseline | Day 0 to Day 42 postoperatively | Vertebral body defect size measured by CT |
| Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline | Day 0 to Day 42 postoperatively | Vertebral body defect size and planar radiographs |
| Change in vertebral body defect size measured by CT at 180 days compared to baseline | Day 0 to Day 180 postoperatively | Vertebral body defect size measured by CT |
| Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline | Day 0 to Day 180 postoperatively | Vertebral body defect size measured by planar radiographs |
| Duration of use of postoperative prescription opioid | Day 180 postoperatively | The average per group duration of intake of opioids in the post-operative setting. |
| Daily dose of postoperative prescription opioid use | Day 180 postoperatively | The average per group dosage of opioids in the post-operative setting. |
| Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure | 30 minutes following the placement of the surgical bandage | 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 |
| Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure | 60 minutes following the placement of the surgical bandage | 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 |
Countries
Canada
Outcome results
None listed