Comparison of Standard SPECT vs xSPECT Reconstruction in the Clinical Management of Patients With Spinal Pain

NCT03702790 | Unknown DMC

• 1 other identifier: 2585
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

SPECT-CT is evolving into an integral part of patient management in those having back pain. It can supplement other types of imaging like MRI by providing physiologic information about the type and location of various disease processes. This information can help guide therapy to the most active sites of disease which MRI and CT cannot do as anatomic imaging modalities. The nuclear department has two cameras that are capable of performing SPECT-CT, an Optima manufactured by GE and a Symbia Intevo Bold manufactured by Siemens. The Optima uses the Volumetrix Evolution algorithm to reconstruct SPECT data that does not incorporate the CT data into these reconstructions. The Bold, on the other hand, has a proprietary reconstruction algorithm called xSPECT which does use the CT data to extract a zone map to better delineate tissue boundaries. In this study, the investigators hope to compare images using the standard and proprietary algorithms to determine if these provide equal or different levels of image interpretation confidence by the reader as well as changes in clinical management.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Measure any change in management in patients with back pain based on results of two different SPECT reconstruction algorithms using a qualitative visual measure.

  GE Optima vs Siemens Intevo

  1 year

Study Arms (1)

Back pain SPECT evaluation

Patients with poorly localized back pain being imaged for clinical decision making

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population are patients with back pain which cannot be definitively localized with other imaging procedures such as x-ray, CT or MRI

You may qualify if:

• Poorly localized back pain in search for guided therapy

You may not qualify if:

• Allergy to MDP, radioisotope used for the examination. Patient limitations may include claustrophobia or inability to complete scan due to pain

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jackson W Kiser, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackson W Kiser, MD

CONTACT

5409817274; jwkiser@carilionclinic.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Molecular Imaging

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 11, 2018
• Study Start: October 10, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)