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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02800551
Eligibility Criteria:
Inclusion Criteria:
* Established histological diagnosis of a malignant primary or metastatic tumor;
* Histologically, radiologically or scintigraphically proven spinal metastasis;
* Pain in the affected spinal region or free of pain under pain medication;
* Age ≥18 years old;
* Karnofsky performance status ≥60%;
* Written informed consent.
Exclusion Criteria:
* Modified Bauer Score \< 2;
* No-mass-type metastatic lesion, defined as a 3D space-occupying lesion visible on CT and/or MR;
* "Radiosensitive" histology of the primary tumor, e.g., lymphoma, small-cell lung cancer, multiple myeloma, germ cell tumors;
* Progressive neurological symptoms/deficit;
* More than 3 affected vertebrae in one target site;
* More than 2 treatment sites;
* Spinal Instability Neoplastic Score (SINS) 13 - 18, i.e., unstable;
* Unable to tolerate treatment (unable to lie flat and immobilized);
* Previous radiotherapy of the region at the level of the affected vertebrae;
* Previous radionuclide therapy within 30 days before stereotactic body radiation therapy;
* Previous surgery (stabilization) of the affected vertebrae;
* Contraindications for MR scanning, e.g., pacemakers;
* Patients with allergy to contrast agents used in computer tomography (CT) and magnetic resonance (MR) imaging or patients who cannot be premedicated to use contrast agent;
* Pregnant or lactating women;
* Women of child bearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment;
* Mental conditions rendering the patient unable to understand the nature, scope, and possible consequences of the study;
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02800551
Study Brief:
Protocol Section:
NCT02800551