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One-Time procedure aims to ease spine cancer pain

NCT ID NCT02987153

Symptom relief Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new approach that combines a minimally invasive spine-stabilizing procedure (kyphoplasty) with a single dose of targeted radiation given during surgery. The goal was to see if this combination could better control pain from cancer that has spread to the spine. Twenty-two adults with unstable or potentially unstable spine metastases and significant pain took part. The treatment delivered radiation directly to the area at highest risk of regrowth, aiming for effective pain relief with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intraoperative radiation therapy (IORT) using the Intrabeam® Photon Radiosurgery System
What this could lead to
If successful, this approach could offer a one-time procedure that stabilizes the spine and provides lasting pain relief for people with cancer that has spread to the spine.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply to everyone. There are risks like infection, wound healing problems, or nerve damage from the radiation or procedure.

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

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Nov 2016

Finished

Oct 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

agnosia metastatic malignant neoplasm in the spinal cord

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal metastases

Contacts and locations

Locations

  • Northwell Health

    Lake Success, New York, 11040, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.