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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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