Dispersal Pattern for Spine Injections (Gadolinium Contrast)

NCT02217280 | Completed Results

• 1 other identifier: 1210810
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to characterize the pattern. Although these procedures are performed with high frequency under the assumption that injectate remains localized to injection site, no peer-reviewed studies have validated this assumption. Comprehensive characterization of injectate dispersal patterns will provide important data regarding safety, as well as diagnostic and therapeutic potential of cervical epidural steroid injections.

Conditions

Cervical Radiculopathy

Keywords

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (2)

• Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.

  Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.

  1 hour

• Circumferential Contrast Spread

  Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane. This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).

  1 hour

Study Arms (1)

Injection with Gadolinium

EXPERIMENTAL

This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.

Drug: Injection with Gadolinium

Interventions

Injection with Gadolinium DRUG

Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system

Also known as: Gadavist

Injection with Gadolinium

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Cervical radiculopathy patient as identified by principle investigator

You may not qualify if:

• Patients unable to give consent or comply with rehabilitation process
• Pregnant
• Co-morbidities such as infection, malignancy, myelopathy or an uncontrolled medical condition
• Allergy to injectate
• Anticoagulative state
• Severe claustrophobia
• Non-MRI compatible pacemaker, neurostimulator, bladder stimulator or other mechanical device
• Renal disease that would cause the patient to be at an increased risk of complication of receiving the contrast agent

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Gadolinium; gadobutrol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Results Point of Contact

• Title: Dr. Christina Goldstein
• Organization: Missouri Orthopaedic Institute

goldsteincl@health.missouri.edu

573-884-9022

Study Officials

• Christina L Goldstein, MD

  University of Missouri Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: August 15, 2014
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Locations

US (1)