Spinal MetastasesKypho-IORTNCT02987153
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
A study testing Kypho-IORT in people with Spinal Metastases, run by Northwell Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Kypho-IORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Approximately 20% of patients with spine metastasis present with unstable lesions, which represent a common therapeutic dilemma in patients with advanced stage cancer and limited survival time. Management necessitates spinal stabilization surgery such as laminectomy, vertebroplasty, or kyphoplasty for mechanical back pain control and irradiation for the underlying malignant process. Because of the limited survival time of patients with metastatic cancer, novel, more convenient treatment concepts to shorten the overall treatment time or hospitalization are desirable. We developed a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases.
Patients treated with Kypho-IORT will receive a prescribed dose of 8 Gy in 1 fraction from The Intrabeam® Photon Radiosurgery System source. The target volume includes only the tumor. The technique of the operation and the delivery of radiotherapy has been described and published previously. TARGiT Academy training and requisite test cases have been completed prior to enrolling subjects on this study. The balloon kyphoplasty, which is an advancement of the vertebroplasty, is a treatment option for fractured vertebral bodies which utilizes bone cement to provide needed support.
Outcome measures will include complete or partial pain relief or a stable response at the index site requiring no increase in narcotic pain medication. Therefore, patients with complete or partial pain relief will be considered responders. Patients with complete or partial pain relief at the index site but a progressive response at the secondary site(s) will be considered non-responders.
Quality of Life Measurements. It is hypothesized that quality of life (QOL) will improve after Kypho-IORT due to rapid and durable pain control after spine treatment. In the current study, we will measure the QOL [EORTC QLQ-C30 (version 3)], the Brief Pain Inventory (BPI), ambulation , and steroid and narcotic use pre- and post-procedure at 1-week, 3-month, 6-month, 9-month, 1-year, and 2-year intervals. The involved spine will be imaged at 3-month intervals up to one year, and at 2 years post-procedure.
All the evidence to date supports the description of the Intrabeam as delivering an accurate and reliable dose. Physicists on site will be responsible for verifying the miniature x-ray source is operational prior to use and setting up the parameters within the control console software for treatment delivery. During the procedure, the control console monitors the system for safe and accurate dose delivery.
- Conditions
- Spinal Metastases
- Being tested
- Kypho-IORT
- Keywords
- Kyphoplasty, Spinal metastases, IORT, Intraoperative radiation therapy, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kypho-IORTRadiation
Also called Intrabeam® Photon Radiosurgery System
The radiation source is inserted into the lesion and switched on for a few minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and clinical applications of this device have been well studied.
| Study group | Role | What they receive |
|---|---|---|
| KYPHO-IORT - 10 Gy and Kyphoplasty | Experimental | Intra-operative radiation therapy followed by standard kyphoplasty Receives: Radiation: Kypho-IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pain control
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.
Measured: 90 days
Secondary outcomes (6)
Feasibility of Kypho-IORT as treatment modality
To determine the feasibility of delivered Kypho-IORT for unstable or potential unstable spine metastases.
Measured: 90 days
Tolerability/side effects
To determine tolerability/side effects of the IORT based on defined MTD criteria (wound healing problems, infection, osteoradionecrosis, nerve and spinal cord damage, pathological fracture, secondary fractures/sintering progression and symptomatic or asymptomatic cement leakage within 90 days.
Measured: 90 days
Local tumor control
Local tumor control is defined as no recurrent tumor in the treated lesion. Patients will be regularly monitored as per the site's policy provided this meets the minimum trial criteria for follow-up with physical examination 1 week post treatment, and at 3 months, 6 months, 1 year, and 2 years post-treatment.
Measured: 2 years
Overall survival
Overall survival will be the time interval between enrollment and death.
Measured: 2 years
Measures of quality of life.
Evaluate the potential benefit of Kypho-IORT on change in and overall quality of life, in pain as measured by the Brief Pain Inventory (BPI); Ambulation, and EORTC QLQ-C30 (version 3).
Measured: 2 years
Steroid and narcotic use.
The average daily morphine equivalent (mgs) used.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Ghaly, Northwell Health
- Investigators
- Maged Ghaly, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987153
- Sponsor's protocol ID
- 15-298
- Acronym
- Kypho-IORT
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
- ClinicalTrials.gov ID
- NCT02987153
- Acronym / sponsor ID
- Kypho-IORT / 15-298
- Conditions
- Spinal Metastases
- Keywords
- Kyphoplasty, Spinal metastases, IORT, Intraoperative radiation therapy, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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.
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
Detailed description
Approximately 20% of patients with spine metastasis present with unstable lesions, which represent a common therapeutic dilemma in patients with advanced stage cancer and limited survival time. Management necessitates spinal stabilization surgery such as laminectomy, vertebroplasty, or kyphoplasty for mechanical back pain control and irradiation for the underlying malignant process. Because of the limited survival time of patients with metastatic cancer, novel, more convenient treatment concepts to shorten the overall treatment time or hospitalization are desirable. We developed a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases.
Patients treated with Kypho-IORT will receive a prescribed dose of 8 Gy in 1 fraction from The Intrabeam® Photon Radiosurgery System source. The target volume includes only the tumor. The technique of the operation and the delivery of radiotherapy has been described and published previously. TARGiT Academy training and requisite test cases have been completed prior to enrolling subjects on this study. The balloon kyphoplasty, which is an advancement of the vertebroplasty, is a treatment option for fractured vertebral bodies which utilizes bone cement to provide needed support.
Outcome measures will include complete or partial pain relief or a stable response at the index site requiring no increase in narcotic pain medication. Therefore, patients with complete or partial pain relief will be considered responders. Patients with complete or partial pain relief at the index site but a progressive response at the secondary site(s) will be considered non-responders.
Quality of Life Measurements. It is hypothesized that quality of life (QOL) will improve after Kypho-IORT due to rapid and durable pain control after spine treatment. In the current study, we will measure the QOL [EORTC QLQ-C30 (version 3)], the Brief Pain Inventory (BPI), ambulation , and steroid and narcotic use pre- and post-procedure at 1-week, 3-month, 6-month, 9-month, 1-year, and 2-year intervals. The involved spine will be imaged at 3-month intervals up to one year, and at 2 years post-procedure.
All the evidence to date supports the description of the Intrabeam as delivering an accurate and reliable dose. Physicists on site will be responsible for verifying the miniature x-ray source is operational prior to use and setting up the parameters within the control console software for treatment delivery. During the procedure, the control console monitors the system for safe and accurate dose delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KYPHO-IORT - 10 Gy and Kyphoplasty | Experimental | Radiation: Kypho-IORTIntra-operative radiation therapy followed by standard kyphoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Kypho-IORTAlso: Intrabeam® Photon Radiosurgery SystemThe radiation source is inserted into the lesion and switched on for a few minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and clinical applications of this device have been well studied. | Radiation | KYPHO-IORT - 10 Gy and Kyphoplasty |
Primary outcome
To evaluate pain control
Time frame: 90 days
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.
6 secondary outcomes
Feasibility of Kypho-IORT as treatment modality
Time frame: 90 days
Tolerability/side effects
Time frame: 90 days
Local tumor control
Time frame: 2 years
Overall survival
Time frame: 2 years
Measures of quality of life.
Time frame: 2 years
Steroid and narcotic use.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. No plan to share data
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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. This study is not recruiting at the moment.
Maged Ghaly, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kypho-IORT in people with Spinal Metastases, run by Northwell Health 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate pain control (time frame: 90 days). 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 15 Jun 2026.