Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study

Completed · Not applicable

Conditions studied: Spinal Metastases

In brief

Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or potentially unstable spinal cord metastases. The primary objective is to evaluate the response rate of pain control when combining kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90 days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral compression fracture

Key facts

Study ID

NCT02987153

Run by

Northwell Health

People needed

22

Starts

2016-11-01

Expected to finish

2022-10-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Karnofsky Index ≥ 60.
• History/physical examination within 4 weeks prior to procedure.
• Imaging of the involved spine within 8 weeks prior to procedure to determine the extent of the spine involvement.
• Numerical Rating Pain Scale within 4 week prior to procedure (score must be ≥ 5 for at least one of the planned sites for spinal IORT.
• Neurological examination within 4 week prior to procedure to rule out rapid neurologic decline.
• Spine Instability Neoplastic Score (SINS score) = ≤12.
• Negative serum pregnancy test within 4 weeks prior to procedure for women of childbearing potential.
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
• The patient must have localized spine metastasis from the T5 to L5 levels by a screening imaging study [bone scan, PET, CT, or MRI] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted). Each of the separate sites have a maximal involvement of ONE vertebral body. Patients can have other visceral metastasis.
• Patients must provide study specific informed consent prior to study entry.

You may not qualify if…

• Spine instability due to a compression fracture; SINS score >12.
• Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord
• Patients with rapid neurologic decline
• Bony retropulsion causing neurologic abnormality
• Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye

Where it is running

• Northwell Health — Lake Success, New York, United States

Full record on ClinicalTrials.gov

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