Proton beam takes aim at spine tumors too complex for standard radiation
NCT ID NCT06895564
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing a precise form of radiation called proton SBRT for people with cancer that has spread to the spine and cannot be treated effectively with standard photon radiation. The study will enroll 12 participants and aims to see if the treatment can be delivered safely and successfully. Researchers will also monitor for nerve-related side effects over the following year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton stereotactic body radiotherapy (SBRT)
- What this could lead to
- If successful, this could offer a new radiation option for patients with spinal tumors that are too complex for standard treatment.
- What could go wrong
- This is a very small pilot study (12 people) testing only feasibility and early safety. It is not designed to prove effectiveness, and the approach may not work for everyone or may cause nerve-related side effects.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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May 2030
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologic proof or unequivocal cytologic proof of nonhematologic malignancy. This may be obtained from either the primary or any metastatic site. 2. Participants must have radiographic evidence of spinal metastasis on MRI. 3. Participants must have a complex case that is unable to be effectively treated with photon SBRT, defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% PTV coverage) with a prescription dose of 30 Gy in 5 fractions. Such cases include: 1. Extensive paraspinal disease 2. Reirradiation setting 3. Epidural extension (Bilsky grade ≥1c) 4. Age ≥ 18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky \>60%). 6. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child. 7. Patients must have the ability to understand and the willingness to sign a written informed consent document. 8. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: 1. Participants may not have a spinal metastases case amenable to standard of care photon SBRT planning techniques that achieve ≥80% PTV coverage with a prescription dose of 30 Gy in 5 fractions. 2. Patients who are unable to receive MRIs will be excluded from the study since MRIs will be critical in treatment planning. 3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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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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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
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