NCT07090122 Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
| NCT ID | NCT07090122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Spine Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-12-01 with a primary completion date of 2028-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Patients will be randomized 2:1 to receive either one treatment of RFA/BA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.
Eligibility Criteria
Inclusion 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: 1. absolute neutrophil count (ANC) ≥ 1.5 × 109/L 2. platelets ≥ 50 × 109/L 3. hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening 4. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN 5. total bilirubin ≤ 1.5 × ULN; \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome 6. serum albumin ≥ 30 g/L (3.0 g/dL) 7. 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: 1. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause 2. 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 Exclusion Criteria: * 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, uncontrolled bleeding diathesis, active infection anywhere in the body, or purely blastic tumor). Note: Mixed lytic/blastic tumors are eligible. * The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion
Contact & Investigator
Reza Talaie
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07090122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07090122 currently recruiting?
Yes, NCT07090122 is actively recruiting participants. Contact the research team at surgCTO@umn.edu for enrollment information.
Where is the NCT07090122 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07090122 clinical trial?
NCT07090122 is sponsored by University of Minnesota. The principal investigator is Reza Talaie at University of Minnesota. The trial plans to enroll 36 participants.