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Study for Spine Metastases and Bone Pain

This study is for people with spine metastases (cancer that has spread to the spine) and bone pain. It compares two ways to treat these conditions: radiofrequency ablation and bone augmentation with radiotherapy versus radiotherapy alone. Radiofrequency ablation uses heat to destroy cancer cells, followed by a bone-strengthening material. Radiotherapy uses high-energy radiation. The study wants to see if adding radiofrequency ablation and bone augmentation reduces skeletal-related events (SREs), which are problems like bone fractures or nerve compression. You may be able to join if you are 18 or older and have confirmed metastatic disease in your spine (T5-L5 area) with pain or imaging that suggests SREs. The study aims to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is a single-center, randomized controlled pilot study. Participants will be randomly assigned to one of two treatment groups, with 36 participants planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for skeletal-related events at 1, 3, 6, 12, and 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07090122

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

Recruiting
NAAges 18+InterventionalTreatment
University of Minnesota
~36 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Radiofrequency ablation and bone augmentation with radiotherapyRadiotherapy alone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Skeletal-related event (SREs) outcomes at 1 month
Measured over Month 1
+4 more outcomes measured

Conditions

Spine Metastases
Bone Pain

Explore related trials

Metastatic Malignant Neoplasm in the Spine

NCT07090122

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Reza Talaie · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Surgery Clinical Trials Office
[email protected]
612-624-7463
Email the study team

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Eligibility criteria

Inclusion

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:
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:
Voluntary written consent prior to the performance of any research related activity

Exclusion

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

What this trial measures

  • Skeletal-related event (SREs) outcomes at 1 monthMonth 1

    Skeletal-related events 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.

  • Skeletal-related event (SREs) outcomes at 3 monthsMonth 3

    Skeletal-related events 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.

  • Skeletal-related event (SREs) outcomes at 6 monthsMonth 6

    Skeletal-related events 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.

  • Skeletal-related event (SREs) outcomes at 12 monthsMonth 12

    Skeletal-related events 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.

  • Skeletal-related event (SREs) outcomes at 24 monthsMonth 24

    Skeletal-related events 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.