BridgeMD
New treatment option for Hematopoietic and Lymphoid Cell Neoplasm
Official title Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
ClinicalTrials.gov ID: NCT05178472
What this study is testing
- What it's testing
- This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age and older with indeterminate Spine Metastasis.
- All patients with histology that requires stereotactic RT as a part of their treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Disease visualized by CT or MRI
- Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
You likely can't join if
- Patients \< 18 years of age
- Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
- Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating...
- Patients with symptomatic spinal cord compression requiring emergent surgery
- Pregnant or lactating women
- Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the...
See the full eligibility criteria
- At least 18 years of age and older with indeterminate Spine Metastasis.
- All patients with histology that requires stereotactic RT as a part of their treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Disease visualized by CT or MRI
- Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
- Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
- Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability...
- Patients \< 18 years of age
- Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
- Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
- Patients with symptomatic spinal cord compression requiring emergent surgery
- Pregnant or lactating women
- Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
- Patients with stable or unstable lesions based on SINS criteria
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.