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3T MRI of Intramedullary Spinal Cord Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05664438
Recruitment Status : Recruiting
First Posted : December 23, 2022
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Study Description
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Brief Summary:

Intramedullary spinal cord tumours (IMSCTs) are a type of tumour that arises from cells within the spinal cord. They are rare, accounting for around 4-10% of central nervous system tumours. They commonly present as back/neck pain and have poor outcomes if not treated.

IMSCTs fall into various subtypes. Around 90% are either ependymomas or astrocytomas. Ependymomas are usually quite distinct from the surrounding tissue and therefore can often be treated successfully with surgery. In contrast, astrocytomas tend to invade the surrounding tissue and, as a result, generally cannot be entirely surgically removed. Radiotherapy is recommended instead of surgery for tumours that cannot be operated. Unfortunately, ependymomas and astrocytomas can appear very similar on diagnostic scans and are therefore difficult to tell apart before surgery. Biopsy therefore remains the current gold standard for tumour subtype differentiation.

Any spinal cord surgery, whether it be biopsy or resection, poses major challenges due to the small size of the spinal cord. A small corridor via the back of the spinal cord, known as the posterior midline, usually offers the safest approach to a tumour. However, finding this access corridor can be very difficult because tumours tend to deform the anatomy of the spinal cord, leading to a high risk of injury to the normal spinal cord tissue or nerves.

The primary objective of this pilot study is to test if cutting-edge spinal cord magnetic resonance imaging (MRI) techniques could help to better differentiate between tumour subtypes. The investigators will do this by comparing various imaging metrics between the tumour subtypes, confirmed by biopsy. The investigators' second objective is to see if these MRI techniques could help to identify, pre-surgery, the location of the posterior midline of the spinal cord. The investigators will do this by comparing the prediction of the midline location from imaging with blinded observations by the surgeon during planned surgery. Additionally, the investigators want to investigate the relationship between imaging metrics and patient pain and sensorimotor symptoms, to explore if imaging offers insight into the variety of clinical symptoms associated with these tumours.

The investigators' hope is that the results of this study could inform a future larger trial that would be designed to fully assess the utility of cutting-edge MRI techniques for reducing both the need for spinal cord surgery and the risks associated with surgery in IMSCT patients.


Condition or disease Intervention/treatment
Spinal Cord Tumor of Cervical Spine Diagnostic Test: MRI scan

Study Design
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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multimodal MRI to Differentiate Subtypes of Intramedullary Spinal Cord Tumours: A Pilot Study
Actual Study Start Date : October 17, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: MRI scan
    MRI scan of cervical spine

Outcome Measures
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Primary Outcome Measures :
  1. Evaluate whether advanced MRI can differentiate between tumour subtypes confirmed by histopathology from biopsy [ Time Frame: Study visit ]
    Compare structural MR imaging metrics, metabolic MR imaging metrics and clinical radiology evidence of bone remodelling, presence of syrinx and presence of haemorrhage between tumour subtypes.


Secondary Outcome Measures :
  1. Determine the added value of advanced MRI features to identify the spinal cord posterior midline [ Time Frame: Study visit and surgery ]
    Compare variations in tissue signal intensity, asymmetry in Tract Density Imaging and asymmetry in vasculature with surgical metrics.

  2. Investigate the relationship between MRI metrics and patient pain and sensorimotor symptoms [ Time Frame: Study visit and surgery ]
    Compare functional MRI activity, functional MRI connectivity and tumour volume/location with pain scores, pain questionnaires, sensorimotor questionnaires/diagrams, overall function scores and overall function questionnaires.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be patients with a diagnosis of IMSCT in the cervical region of the spinal cord. We will aim to recruit approximately 50% ependymoma and 50% astrocytoma patients.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or Female, aged 18 years or above
  • Radiological diagnosis of IMSCT in the cervical spinal cord
  • Planned to undergo a biopsy or has already undergone a biopsy to determine tumour subtype
  • Sufficient remnant tumour as decided by the study team by review of patients clinical radiological scans

Exclusion Criteria:

  • Contraindication to MRI, including certain metal implants
  • Subjects who are pregnant or planning pregnancy
  • Any previous therapy that could in the opinion of the CI confound the research MRI characteristics
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05664438


Contacts
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Contact: Jessica Walsh, PhD 01865 611450 jessica.walsh@ndcn.ox.ac.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Jessica Walsh, PhD       jessica.walsh@ndcn.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT05664438    
Other Study ID Numbers: 15346
First Posted: December 23, 2022    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases