3T MRI of Intramedullary Spinal Cord Tumours
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|ClinicalTrials.gov Identifier: NCT05664438|
Recruitment Status : Recruiting
First Posted : December 23, 2022
Last Update Posted : December 23, 2022
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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 Type :||Observational|
|Estimated Enrollment :||12 participants|
|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|
- Diagnostic Test: MRI scan
MRI scan of cervical spine
- 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.
- 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.
- 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.
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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|
- 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
- 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
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
|Contact: Jessica Walsh, PhD||01865 email@example.com|
|John Radcliffe Hospital||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Contact: Jessica Walsh, PhD firstname.lastname@example.org|
|Responsible Party:||University of Oxford|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases