| NCT ID | NCT06895564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Spinal Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 12 participants in total. It began in 2025-04-22 with a primary completion date of 2030-04.
⚠ 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-arm pilot study of proton stereotactic body radiotherapy (SBRT) for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% planning treatment volume (PTV) coverage)) with a prescription dose of 30 Gy in 5 fractions.
Eligibility Criteria
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.
Contact & Investigator
Kristin Redmond, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06895564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895564 currently recruiting?
Yes, NCT06895564 is actively recruiting participants. Contact the research team at kjanson3@jhmi.edu for enrollment information.
Where is the NCT06895564 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06895564 clinical trial?
NCT06895564 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Kristin Redmond, MD at Johns Hopkins University. The trial plans to enroll 12 participants.