Recruiting
Phase 1

Intraoperative Radiotherapy & Kyphoplasty

Sponsor:

Loyola University

Code:

NCT02480036

Conditions

Spinal Metastasis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

IORT with Kyphoplasty

Intrabeam®

Study Details

Brief summary:

The primary objective is to evaluate the tolerability (side effects) of the intraoperative radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord damage, and pathological fracture), and the secondary objective is to evaluate the effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).

Conditions

Spinal Metastasis

Study ID

NCT02480036

Start date

Dec, 2014

Status verified date

Sep, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Metastatic patients from solid tumor
  • Estimated life expectancy of at least 3 months
  • Age >= 50 years.
  • Karnofsky Performance Status >= 70%
  • Numeric Pain Intensity Score >= 3
  • 10% or more loss of vertebrae height
  • Adequate organ and marrow function as defined below:
  • International normalized ratio (INR)/ prothrombin time (PT) within normal institutional limits
  • leukocytes >= 3,000 microliter (mcL)
  • Absolute neutrophil count >= 1,500 mcL
  • Platelets >= 100,000 mcl
  • Total bilirubin within normal institutional limits
  • Abnormal aspartate transaminase (AST or SGOT) or alanine transaminase (ALT or SPGT)
  • Abnormal creatinine
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who have had prior external beam radiotherapy or surgery in the area of planned intervention
  • Previous radiopharmaceuticals (i.e, Ra-222, Sr-90, etc) within 30 days of procedure
  • Patients who are receiving systemic therapy (chemotherapy, hormonal, immunotherapy, bisphosphonates, etc) or other investigational agents are eligible if the systemic therapy can be safely held two weeks prior to procedure. These therapies may be resumed two weeks after the procedure
  • Primary hematologic malignancies
  • Patients with clinical or radiographic evidence of spinal cord or cauda equine compression or effacement
  • Chronic vertebrae fracture of greater than 6 months or coexisting bilateral pedicle fracture
  • Previous kyphoplasty in the same area
  • Patients with severe spinal deformity requiring open reconstruction or extreme adiposity, in which determining placement of metal sleeve would be difficult by fluoroscopy (limited bone margin)
  • History of allergic reactions attributed to compounds of similar composition to agents used for kyphoplasty
  • Uncontrolled medical 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
  • Pre-menopausal female

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined IORT and Kyphoplasty

IORT with Kyphoplasty IORT Device: Intrabeam®

Interventions

IORT with Kyphoplasty

IORT with kyphoplasty is give concurrently for the treatment of spinal metastases

Intrabeam®

Primary outcome measure

  • Pain [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Beth Chiappetta, BSN

708-216-2568bchiappetta@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Beth Chiappetta, BSN

708-216-2568bchiappetta@lumc.edu

Principal Investigator:

William Small, MD

More Information

Sponsor

Loyola University

Last update posted

Sep 7, 2020

Last verified

Sep, 2020

Keywords

  • IORT
  • Kyphoplasty
  • Spine
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2020-09-07.