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Clinical Trials

The Duke Center for Brain and Spine Metastasis at DCI research team collectively offers a range of clinical trials for patients with brain and spine metastasis, including those with recurrent or previously untreated disease. In a clinical trial, a new therapy or therapy combination is evaluated to determine it if is more effective than the current standard therapy. As a patient at the center you may be able to participate in a clinical trial. The clinical trials lead by our research team are improving the way we diagnose and treat brain and spine metastasis.

For more information about these trials and/or to enroll, please contact Natalie Ashley, patient navigator, at 919.681.3038.

Spine Tumor
Metastatic Tumor Research and Outcomes Network (MTRON)
Brief Summary:
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

OsteoCool Tumor Ablation Post-Market Study (OPuS One)
Brief Summary:
The purpose of this study is to determine the effectiveness of OsteoCool RF Ablation system in patients with metastatic malignant lesions in a vertebral body or painful metastatic lesions involving bone who have failed or were not candidates for standard therapy.
 
Radiation Oncology
A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
Brief Summary:
This protocol is for a lead-in safety study of five patients followed by a randomized Phase 2 clinical trial of BMX-001, a new class of pharmaceutical, in 64 patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT). Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.
 
SIMT Stereotactic Radiosurgery Outcomes Study (SIMT)
Brief Summary:
The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastasis.