Clinical trial NCT05280067: Feasibility Study of ZetaFuse(TM) Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body
Official title: Feasibility Study of ZetaFuse(TM) Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Breast Cancer in the Spine
Keywords: Metastatic Breast Cancer
Bone Metastases
Spine Metastases
Vancouver
Metastatic Breast Cancer to Bone
X-radiation therapy
Lead sponsor: Zetagen Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 10
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Number of Skeletal Related Events (SREs)
timeFrame: Day 0 up to Day 180
measure: Number of subjects with at least one adverse event (AE)
timeFrame: Day 0 up to Day 180
measure: Number of subjects with at least one procedure-related AE
timeFrame: Day 0 up to Day 180
measure: Number of subjects with at least one device-related AE
timeFrame: Day 0 up to Day 180
measure: Change in SINS assessment at 21 days compared to baseline
timeFrame: Day 0 to Day 21 postoperatively
measure: Change in SINS assessment at 42 days compared to baseline
timeFrame: Day 0 to Day 42 postoperatively
measure: Change in SINS assessment at 84 days compared to baseline
timeFrame: Day 0 to Day 84 postoperatively
measure: Change in SINS assessment at 180 days compared to baseline
timeFrame: Day 0 to Day 180 postoperatively
measure: Change in Short Form 12v2 (SF-12v2) score compared to baseline
timeFrame: Day 0 to Day 180 postoperatively
measure: Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline
timeFrame: Day 0 to Day 21 postoperatively
measure: Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline
timeFrame: Day 0 to Day 42 postoperatively
measure: Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline
timeFrame: Day 0 to Day 84 postoperatively
measure: Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline
timeFrame: Day 0 to Day 180 postoperatively
measure: Change in vertebral body defect size measured by CT at 42 days compared to baseline
timeFrame: Day 0 to Day 42 postoperatively
measure: Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline
timeFrame: Day 0 to Day 42 postoperatively
measure: Change in vertebral body defect size measured by CT at 180 days compared to baseline
timeFrame: Day 0 to Day 180 postoperatively
measure: Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline
timeFrame: Day 0 to Day 180 postoperatively
measure: Duration of use of postoperative prescription opioid
timeFrame: Day 180 postoperatively
measure: Daily dose of postoperative prescription opioid use
timeFrame: Day 180 postoperatively
measure: Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure
timeFrame: 30 minutes following the placement of the surgical bandage
measure: Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure
timeFrame: 60 minutes following the placement of the surgical bandage
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References: