Clinical Trials / Research Studies

Clinical Trials / Research Studies

Who can participate?

Inclusion Criteria:

• Patient age at least 18 years
• Up to 3 painful bone metastasis(-es) in the extremities
• Bone metastases that can be treated using pre-defined treatment field sizes (7.5 cm x 7.5 cm; 7.5 cm x 10 cm; 7.5 cm x 12 cm; 7.5 cm x 14 cm; 7.5 cm x 16 cm; 7.5 cm x 18 cm; 7.5 cm x 20 cm), without overlap of radiation fields
• Life expectancy of >2 months (in the judgement of the investigator)
• Patients who are able to comply with the protocol
• Provision of signed and dated informed consent form

Exclusion Criteria:

• Prior radiotherapy to the treatment site(s)
• Lesions of the feet, hands, wrists are not eligible treatment sites for FLASH
• More than 3 painful bone metastases of the limbs requiring palliative radiotherapy
• Tumor lysis of >50% of the circumferential bone cortex, or other factors considered to place the subject at significant risk of pathologic fracture
• Patients with bone fractures and/or metal implants in the treatment field
• Patients with a diagnosis of hematological malignancy
• Patients who will receive cytotoxic chemotherapy within 1 week prior to or 1 week following their planned radiation treatment
• Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment
• Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy
• Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation
• Patients at known risk of enhanced normal tissue sensitivity to radiotherapy due to inherited predisposition or documented comorbidity that might lead to hypersensitivity to ionizing radiation
• Patients enrolled in any other clinical studies the investigator believes to be in conflict with this clinical investigation.
• Patients who are pregnant or nursing