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

Korábbi kezelés

• 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).

Más betegség

• Uncontrolled diabetes mellitus, HbAIC cutoff.
• An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
• 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.

Egyéb

• Vertebral body collapse.
• Spinal cord compression.
• Current tobacco smoker or stopped smoking in past 6 months.
• Currently participating in any investigational trial not related to this trial.
• Pregnant or planning to become pregnant during the trial.

• 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.