Evaluating ZetaMet Via Outpatient Local Intratumoral Injection Procedure to Treat Breast Cancer Bone Metastases in the Spine to Control Pain and Prevent Complications Such as Fracture

Phase 2

Active, not recruiting

• Conditions: Metastatic Breast Cancer in the Spine
• Interventions: Device: ZetaFuse™ Bone Graft

• Registration Number: NCT05280067
• Lead Sponsor: Zetagen Therapeutics, Inc

Brief Summary

ZetaMet™ (ZetaFuse™ Bone Graft) 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™ (ZetaFuse™ Bone Graft) is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ (ZetaFuse™ Bone Graft) 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™ (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.

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-15
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Device The ZetaFuse™ Bone Graft	ZetaFuse™ Bone Graft	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.

Primary Outcome Measures

Name	Time	Method
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
Daily dose of postoperative prescription opioid use	Day 180 postoperatively	The average per group dosage of opioids in the post-operative setting.
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 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 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
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.
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
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.
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 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.
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 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 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 180 days compared to baseline	Day 0 to Day 180 postoperatively	Vertebral body defect size measured by planar radiographs
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.
Duration of use of postoperative prescription opioid	Day 180 postoperatively	The average per group duration of intake of opioids in the post-operative setting.

Trial Locations

Locations (2)

Vancouver Coastal Health Research Institute; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Center; 🇨🇦 Montréal, Quebec, Canada