Spine MetastasesNCT07090122
Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
A study testing Radiofrequency ablation and bone augmentation with radiotherapy and Radiotherapy alone in people with Spine Metastases and Bone Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastases, Bone Pain
- What is being tested?
- Radiofrequency ablation and bone augmentation with radiotherapy and Radiotherapy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 13 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Deb Mailand, 612-626-2498, mailand@umn.edu
About this study
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.
- Conditions
- Spine Metastases, Bone Pain
- Being tested
- Radiofrequency ablation and bone augmentation with radiotherapy, Radiotherapy alone
- Keywords
- Radiofrequency ablation (RFA), Bone augmentation (BA), Radiotherapy (RT), Metastatic disease of the spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation and bone augmentation with radiotherapyProcedure or surgery
employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
Radiotherapy aloneProcedure or surgery
High-energy radiation
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation and bone augmentation with radiotherapy | Active comparator | Radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size Receives: Procedure: Radiofrequency ablation and bone augmentation with radiotherapy |
| Radiotherapy alone | Placebo comparator | ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size Receives: Procedure: Radiotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal-related event (SREs) outcomes at 1 month
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.
Measured: Month 1
Skeletal-related event (SREs) outcomes at 3 months
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.
Measured: Month 3
Skeletal-related event (SREs) outcomes at 6 months
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.
Measured: Month 6
Skeletal-related event (SREs) outcomes at 12 months
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.
Measured: Month 12
Skeletal-related event (SREs) outcomes at 24 months
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.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Dec 2025
- Primary completion13 Jan 2028 (estimated)
- Study completion13 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, randomized 2 arm controlled pilot study
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Talaie, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090122
- Sponsor's protocol ID
- RAD-2023-32509
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
- ClinicalTrials.gov ID
- NCT07090122
- Acronym / sponsor ID
- RAD-2023-32509
- Conditions
- Spine Metastases, Bone Pain
- Keywords
- Radiofrequency ablation (RFA), Bone augmentation (BA), Radiotherapy (RT), Metastatic disease of the spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 13 Jan 2028 (estimated)
- Study completion
- 13 Jun 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-center, randomized 2 arm controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation and bone augmentation with radiotherapy | Active comparator | Procedure: Radiofrequency ablation and bone augmentation with radiotherapyRadiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size |
| Radiotherapy alone | Placebo comparator | Procedure: Radiotherapy aloneONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation and bone augmentation with radiotherapyemploys radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent | Procedure or surgery | Radiofrequency ablation and bone augmentation with radiotherapy |
| Radiotherapy aloneHigh-energy radiation | Procedure or surgery | Radiotherapy alone |
Primary outcome
Skeletal-related event (SREs) outcomes at 1 month
Time frame: Month 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 months
Time frame: Month 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 months
Time frame: Month 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 months
Time frame: Month 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 months
Time frame: Month 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reza Talaie principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation and bone augmentation with radiotherapy and Radiotherapy alone in people with Spine Metastases and Bone Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surgery Clinical Trials Office (612-624-7463, surgCTO@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal-related event (SREs) outcomes at 1 month (time frame: Month 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.