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

Primary Purpose

Metastatic Breast Cancer in the Spine

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ZetaFuse™ Bone Graft
Sponsored by
Zetagen Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Metastatic Breast Cancer in the Spine

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Vancouver Coastal Health Research Institute
  • McGill University Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Device The ZetaFuse™ Bone Graft

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Safety Evaluation
Safety will be characterized by a summary of the incidence of adverse events (AEs), procedure-related AEs, and device-related AEs.
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.
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.
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.
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.
Duration of use of postoperative prescription opioid use.
Use of opioids in the post-operative setting will be evaluated for duration of use.
Average daily dose of postoperative prescription opioid use.
Use of opioids in the post-operative setting will be evaluated for dosage.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2022
Last Updated
July 25, 2023
Sponsor
Zetagen Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05280067
Brief Title
ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body
Acronym
ZGMBC
Official Title
Feasibility Study of ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zetagen Therapeutics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer in the Spine

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device The ZetaFuse™ Bone Graft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ZetaFuse™ Bone Graft
Intervention Description
The ZetaFuse™ Bone Graft will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.
Primary Outcome Measure Information:
Title
Device Feasibility and Preliminary Effectiveness as measured In Number of Skeletal Related Events (SRE) by 180-day follow-up visit.
Description
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.
Time Frame
6 months
Title
Safety Evaluation
Description
Safety will be characterized by a summary of the incidence of adverse events (AEs), procedure-related AEs, and device-related AEs.
Time Frame
6 months
Title
Change in SINS assessment compared to baseline.
Description
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.
Time Frame
6 months
Title
Short Form 12v2 (SF-12v2) at 180-day follow-up visits compared to baseline
Description
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.
Time Frame
6 months
Title
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) compared to baseline.
Description
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.
Time Frame
6 months
Title
Change in vertebral body defect size at 42- and 180-day follow-up visits compared to baseline.
Description
CT and Planar Radiographs will be given at baseline, 42- and 180-days post operatively.
Time Frame
6 months
Title
Duration of use of postoperative prescription opioid use.
Description
Use of opioids in the post-operative setting will be evaluated for duration of use.
Time Frame
6 months
Title
Average daily dose of postoperative prescription opioid use.
Description
Use of opioids in the post-operative setting will be evaluated for dosage.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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