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Compares treatment options for Spine Metastases
Official title Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
ClinicalTrials.gov ID: NCT07090122
What this study is testing
- What it's testing
- This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA/BA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine.
- 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
- Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.
- Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.
- Age 18 years of age or older at the time of consent.
- Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:
- absolute neutrophil count (ANC) ≥ 1.5 × 109/L
You likely can't join if
- Pregnant or breastfeeding.
- Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.
- Prior radiation therapy to the target lesion.
- Candidates for spine stabilization surgery.
- The target lesion(s) is deemed ineligible for RFA/BA (e.g. unstable existing fractures/impending fractures, involvement of the posterior elements...
- The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion
See the full eligibility criteria
- Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.
- Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.
- Age 18 years of age or older at the time of consent.
- Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:
- absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- platelets ≥ 50 × 109/L
- hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
- total bilirubin ≤ 1.5 × ULN; \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
- serum albumin ≥ 30 g/L (3.0 g/dL)
- serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula
- Persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment.
- Persons are considered to be of childbearing potential unless one or the following applies:
- Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
- Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy
- Voluntary written consent prior to the performance of any research related activity
- Pregnant or breastfeeding.
- Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.
- Prior radiation therapy to the target lesion.
- Candidates for spine stabilization surgery.
- The target lesion(s) is deemed ineligible for RFA/BA (e.g. unstable existing fractures/impending fractures, involvement of the posterior elements, retropulsion, spinal canal narrowing, neuroforaminal narrowing...
- The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, 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 Minneapolis, Minnesota, 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.