Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT02773966
Eligibility Criteria:
Inclusion Criteria:
* ≥ 50 years
* Karnofsky Index ≥ 60
* Initial pain score using the VAS ≥ 3 under standard pain medication
* Histological or by imaging proven painful osteolytic metastases (max. 4 treatable vertebrae) of the thoracic/lumbar spine, which are accessible for Kypho-IORT
* Written informed consent obtained
* Exclusion Criteria:
* Previous local treatment (irradiation, surgery)
* Cranial site of the metastasis above T4
* Pathological fracture with sintering \>50%
* Purely osteoblastic metastasis
* Intraspinal extension
* Erosion of the bony borders of the vertebra which make a cement filling difficult, rated by the treating surgeon
* Tumor expansion to dorsal vertebral structures (pedicle, lamina)
* Pregnancy/lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02773966
Study Brief:
Protocol Section:
NCT02773966