Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

Launched by KUROS BIOSURGERY AG · Apr 11, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects 6 - 16 years of age
• 2. Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:
• • Cyst fluid examination
• • Plain radiographs
• • MRI
• 3. Subjects with the following types of cysts:
• • Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
• • Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
• • Persistence of a cyst cavity despite repeated interventions
• • 4. Subjects with bone cyst volumes \< 30 mL
• • 5. Subjects must be appropriately communicative to verbalise pain.
• • 6. Subjects must be able to understand and be willing to comply with the protocol procedures.
• • 7. Subjects who have provided written informed consent to participate in the study
• • 8. The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.
• Exclusion Criteria:
• • 1. A history of/or presence of active cancer
• • 2. Family history of retinoblastoma
• • 3. Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
• • 4. Possible presence of osteosarcoma or uncertain histology
• • 5. Systemic or localised infection at time of surgery
• • 6. Evidence of immune-suppression
• • 7. Evidence of hypercalcemia
• • 8. Cyst volume \> 30 mL
• • 9. Fracture present in the cortical bone surrounding the cyst
• • 10. Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.
• • 11. Suspected or known evidence of allergic reactions towards any of the components of I-040302
• • 12. Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study
• • 13. Pregnant or lactating females
• • 14. Participation in another clinical trial within 3 months prior to trial start