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

NCT02987153 | Completed DMC

• 1 other identifier: 15-298
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Spinal Metastases

Keywords

Kyphoplasty; Spinal metastases; IORT; Intraoperative radiation therapy; Pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (6)

• Feasibility of Kypho-IORT as treatment modality

  90 days

• Tolerability/side effects

  90 days

• Local tumor control

  2 years

• Overall survival

  2 years

• Measures of quality of life.

  2 years

Study Arms (1)

KYPHO-IORT - 10 Gy and Kyphoplasty

EXPERIMENTAL

Intra-operative radiation therapy followed by standard kyphoplasty

Radiation: Kypho-IORT

Interventions

Kypho-IORT RADIATION

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.

Also known as: Intrabeam® Photon Radiosurgery System

KYPHO-IORT - 10 Gy and Kyphoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

Lake Success, New York, 11040, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maged Ghaly, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor of Radiation Medicine

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)