Comparison of Clinical Impact in the Management of Patients With Spinal Pain Being Evaluated With Conventional SPECT Reconstruction vs. xSPECT
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|ClinicalTrials.gov Identifier: NCT03702790|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Comparison of Standard SPECT vs xSPECT Reconstruction in the Clinical Management of Patients With Spinal Pain.|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||November 2019|
Back pain SPECT evaluation
Patients with poorly localized back pain being imaged for clinical decision making
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702790
|Contact: Jackson W Kiser, MDfirstname.lastname@example.org|