Heat and cement: a new One-Two punch for spine cancer?
NCT ID NCT07090122
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether using radiofrequency ablation (heat to kill cancer cells) plus bone cement to stabilize the spine, followed by radiation, works better than radiation alone for people with cancer that has spread to the spine. The goal is to see if the combination reduces fractures, nerve problems, and pain. Thirty-six adults with spine metastases will be randomly assigned to receive the combination or radiation alone, and they will be followed for up to two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency ablation and bone augmentation (bone cement) plus radiotherapy
- What this could lead to
- If it works, this combination could reduce fractures, spinal cord compression, and the need for additional surgeries in people with cancer that has spread to the spine.
- What could go wrong
- This is a very small pilot study with only 36 participants, so results may not apply to everyone. The procedure carries risks like infection, bleeding, or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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- Double attack on spine tumors: heat then zap