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Dispersal Pattern for Spine Injections (Gadolinium Contrast)

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ClinicalTrials.gov Identifier: NCT02217280
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Christina Goldstein, University of Missouri-Columbia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Cervical Radiculopathy
Intervention Drug: Injection with Gadolinium
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervical ESI With Gadolinium
Hide Arm/Group Description Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Reason Not Completed
Withdrawal by Subject             2
Post-consent sceen fail             2
Arm/Group Title Cervical ESI With Gadolinium
Hide Arm/Group Description Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
51.18
(39 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
 100.0%
1.Primary Outcome
Title Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injection With Gadolinium
Hide Arm/Group Description:

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.

Injection with Gadolinium: 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

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: cm
14.73  (3.15)
2.Primary Outcome
Title Circumferential Contrast Spread
Hide Description

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).

Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervical ESI
Hide Arm/Group Description:
Male and female subjects between the ages of 18-85 with cervical radiculopathy. This was a single arm study.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
Time Frame 1 year
Adverse Event Reporting Description Regular investigator assessment
 
Arm/Group Title Cervical ESI With Gadolinium
Hide Arm/Group Description Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance.
All-Cause Mortality
Cervical ESI With Gadolinium
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cervical ESI With Gadolinium
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cervical ESI With Gadolinium
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Christina Goldstein
Organization: Missouri Orthopaedic Institute
Phone: 573-884-9022
Responsible Party: Christina Goldstein, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02217280     History of Changes
Other Study ID Numbers: 1210810
First Submitted: March 21, 2014
First Posted: August 15, 2014
Results First Submitted: April 18, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017