Active — Not RecruitingNot Applicable

Quantitative Imaging of Cervical Spinal Structures - the DISC Pilot Study -

Netherlands40 participantsStarted 2024-07-26

Plain-language summary

The aim of this study is to explore a multi-parametric quantitative MRI approach to measure cervical intervertebral discs, the spinal cord and its nerve roots in healthy participants and patients with cervical degenerative disc disease (CDDD). CDDD is the consequence of degeneration of intervertebral discs and joints leading to symptoms of cervical radiculopathy, myelopathy, or a combination of both. The incidence of symptomatic CDDD is rising with the aging population, and, consequently, a significant increase in surgeries for symptomatic CDDD is predicted in the upcoming years. However, the decision for- and optimal timing of surgery remain challenging. Currently, the decision for surgery in patients with symptomatic CDDD is related to symptoms, as well as position and size of disc herniation on conventional Magnetic Resonance Imaging (MRI). However, conventional MRI only enables qualitative morphological evaluation, leaving space for subjective individual interpretation. Also, disc herniations on conventional MRI are frequently found in asymptomatic individuals, while, in symptomatic individuals type and extent of disc herniation does not correlate to severity of symptoms. Altogether, the current standard using conventional MRI cannot optimally predict response to surgery for patients with symptomatic CDDD. The primary aim of this project is to investigate whether a combination of different quantitative imaging sequences can provide more detailed information on disc herniation related compression and potentially aid in determining more objective cut-offs to stage disc herniation in patients with symptomatic CDDD, as well as to analyze whether differences exist in quantitative imaging parameters of discs in healthy participants versus patients with symptomatic CDDD. These novel techniques are promising, as they are noninvasive and could potentially aid in determining objective cut-offs to stage disc herniation. Since no single measurement has been proven to be the golden standard in previous studies, it is likely that a combination of measurements is needed for clinical application

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with symptomatic CDDD * Age ≥18 years * One-level or 2-level symptomatic CDDD (radiculopathy, myelopathy or radiculomyelopathy) of cervical levels C4-5, C5-6l, C6-7 or C7-Th1. * Sufficient understanding of spoken and written Dutch language * Agrees to participate in the obligatory measurements of this study and signed informed consent prior to any study-related procedures. * Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary. Healthy participants * Age-matched healthy participant. * Sufficient understanding of spoken and written Dutch language. * Agrees to participate in the obligatory measurements of this study and signed informed consent prior to any study-related procedures. * Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary Exclusion Criteria: Patients with symptomatic CDDD * Multi-segmental (3 or more segments) symptomatic CDDD. * Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy). * A positive pregnancy test. * Allergy for contrast medium. * Previous history of cervical spine surgery. Healthy participants * Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy). * A positive pregnancy test. * Allergy for contrast medium. * Previous history of cervical spin…

What they're measuring

Quantitative MRI sequences

Timeframe: MRI conducted at study visit (baseline)

Clinical correlation of quantitative MRI sequences and clinical impairment in patients with symptomatic CDDD

Timeframe: MRI and clinical examinations conducted at study visit (baseline)

To determine a correlation between baseline quantitative MRI sequences of cervical spinal structures and surgical treatment after 6 months of follow-up in patients with symptomatic CDDD as well as clinical outcomes assessed at 6 months of follow-up.

Timeframe: 6 months

Comparison CSI

Timeframe: During first study visit

Trial details

NCT IDNCT06610175

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Cervical Radiculopathy trials