Skip to main content
OpenTrials
Completed

NCT Number: NCT05280067

ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer in the Spine Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

22 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZetaMet™ (ZetaFuse™ Bone Graft)

Combination Product

ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.

Primary outcomes

  1. Number of Skeletal Related Events (SREs)

    Time frame: Day 0 up to Day 180

    SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.

  2. Number of subjects with at least one adverse event (AE)

    Time frame: 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.

  3. Number of subjects with at least one procedure-related AE

    Time frame: 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.

  4. Number of subjects with at least one device-related AE

    Time frame: 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.

  5. Change in SINS assessment at 21 days compared to baseline

    Time frame: 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.

  6. Change in SINS assessment at 42 days compared to baseline

    Time frame: 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.

  7. Change in SINS assessment at 84 days compared to baseline

    Time frame: 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.

  8. Change in SINS assessment at 180 days compared to baseline

    Time frame: 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.

  9. Change in Short Form 12v2 (SF-12v2) score compared to baseline

    Time frame: 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.

  10. Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline

    Time frame: 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.

  11. Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline

    Time frame: 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.

  12. Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline

    Time frame: 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.

  13. Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline

    Time frame: 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.

  14. Change in vertebral body defect size measured by CT at 42 days compared to baseline

    Time frame: Day 0 to Day 42 postoperatively

    Vertebral body defect size measured by CT

  15. Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline

    Time frame: Day 0 to Day 42 postoperatively

    Vertebral body defect size and planar radiographs

  16. Change in vertebral body defect size measured by CT at 180 days compared to baseline

    Time frame: Day 0 to Day 180 postoperatively

    Vertebral body defect size measured by CT

  17. Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline

    Time frame: Day 0 to Day 180 postoperatively

    Vertebral body defect size measured by planar radiographs

  18. Duration of use of postoperative prescription opioid

    Time frame: Day 180 postoperatively

    The average per group duration of intake of opioids in the post-operative setting.

  19. Daily dose of postoperative prescription opioid use

    Time frame: Day 180 postoperatively

    The average per group dosage of opioids in the post-operative setting.

  20. Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure

    Time frame: 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

  21. Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zetagen Therapeutics, Inc

Industry

Registry information

Official study title

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

Acronym: ZGMBC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.