- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702790
Comparison of Standard SPECT vs xSPECT Reconstruction in the Clinical Management of Patients With Spinal Pain
Comparison of Clinical Impact in the Management of Patients With Spinal Pain Being Evaluated With Conventional SPECT Reconstruction vs. xSPECT
Study Overview
Status
Conditions
Detailed Description
Study objectives are: 1. Compare image quality between the Optima and Intevo as primary objective and 2.Does one device produce images that are more impactful on clinical management as a secondary objective.
The investigators have used both the Optima and Bold in their clinical practice for the evaluation of back pain in patients referred from sports medicine physicians and orthopedic spine surgeons. The two scanners and respective reconstruction algorithm software create distinctly different image sets. The investigators would like to do side by side comparison to determine if one device produces images of greater clinical value than the other.When patient is referred for a SPECT-CT scan for back pain, a standard injection of approximately 25mCi of MDP will be given. The patient will be then be randomly assigned to be scanned to either the Optima or the Intevo to be followed by scan on the other of the 2 scanners. Patients will be randomized as to the sequence of which scanner is used first or second so as to eliminate any potential bias that might occur due to variable uptake time of the radioisotope.
When scans are completed, images will be reviewed on PACS display and comparison will be made. Input as to the clinical impact of the images will also be assessed by the referring physicians to determine if one of the two scanners has superiority.
From the time of injection to the completion of both scans will be approximately 5 hours including a standard 3 hour uptake time after injection of the radioisotope. The scans will all be done on the same day with no return visits necessary. The interpreting radiologist will be blinded as to which scanner produced the images. Similarly, the referring physician will also be blinded when reviewing the images and determining patient management.The ordered exam is the standard of care and no ongoing treatments/therapies will be interrupted.
Study does not involve administering a therapy that would or would not be ultimately prescribed by the referring physician. Only exclusion criteria would be a known allergy to MDP used as the injected isotope. Pregnancy and claustrophobia that would prevent the patient from tolerating the SPECT-CT device would also be contraindications. The device is not experimental; it is an ongoing part of patient evaluation for back pain. The study wants to compare the impact of images using two separate reconstruction algorithms to determine superiority if present in the setting of clinical practice.
There is a very low risk of additional radiation exposure from the second low dose CT as part of the second SPECT-CT scan. Estimated additional exposure beyond dose administered for standard prescribed imaging protocol is approximately 1mSv or less. ALARA principles will be used as with all patients to use only as much dose as necessary to generate images.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Virginia
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Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Roanoke Memorial Hospital
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Contact:
- Jackson W Kiser
- Phone Number: 540-981-7274
- Email: jwkiser@carilionclinic.org
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Contact:
- Jessica Mays
- Phone Number: 5409858067
- Email: jlmays@carilionclinic.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Poorly localized back pain in search for guided therapy
Exclusion Criteria:
- Allergy to MDP, radioisotope used for the examination. Patient limitations may include claustrophobia or inability to complete scan due to pain
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Back pain SPECT evaluation
Patients with poorly localized back pain being imaged for clinical decision making
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure any change in management in patients with back pain based on results of two different SPECT reconstruction algorithms using a qualitative visual measure.
Time Frame: 1 year
|
GE Optima vs Siemens Intevo
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jackson W Kiser, MD, Carilion Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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