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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT02464761
Eligibility Criteria:
Inclusion Criteria:
* Age between 20 and 85
* Established metastatic vertebral bony disease in the spine
* Eligible for single level vertebral osteoplasty (i.e. percutaneous vertebroplasty, kyphoplasty)
* Patients who are symptomatic with axial pain from vertebral metastatic involvement and are at risk for pathologic fracture; or have had a symptomatic pathologic fracture
* Patients who have shown radiographic progression and/or pain symptoms of a documented vertebral metastasis despite non-surgical therapies
Exclusion Criteria:
* Progressive neurological compromise
* Osteoblastic vertebral metastatic disease
* Posterior vertebral cortical/body wall involvement
* Spinal canal compromise / neurologic compression
* Anticipated life expectancy of less than twelve weeks to live
* Cognitive impairment and/or language barriers to study participation
* Severe hepatic impairment (Child's C) with active hepatitis or hepatic disease.
* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. CNS metastases must be stable for \> 2 weeks prior to screening.)
* Nursing mothers, pregnant, currently breastfeeding or trying to get pregnant.
* Unable to avoid sun exposure for 5 day post-PDT therapy (per verteporfin precautions).
* Hyperphotosensitivity conditions, including porphyria
* Hypersensitivity to verteporfin or any other ingredients of Visudyne
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02464761
Study Brief:
Protocol Section:
NCT02464761