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Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases

NCT02480036 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-09-07

No results posted yet for this study

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

Interventions

RADIATION

IORT with Kyphoplasty

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

DEVICE

Intrabeam®

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • William Small, MD · Loyola University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02480036 on ClinicalTrials.gov