An observational study in Spinal Cord Tumor of Cervical Spine, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by University of Oxford · Observational
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.
88 studies on the registry are indexed under Spinal Cord Neoplasms; 26 are open to participants now.
This study's planned enrollment of 12 is below the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord Neoplasms studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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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.
Exclusion Criteria:
MRI scan of cervical spine
Evaluate whether advanced MRI can differentiate between tumour subtypes confirmed by histopathology from biopsy
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.
Time frame: Study visit
Determine the added value of advanced MRI features to identify the spinal cord posterior midline
Compare variations in tissue signal intensity, asymmetry in Tract Density Imaging and asymmetry in vasculature with surgical metrics.
Time frame: Study visit and surgery
Investigate the relationship between MRI metrics and patient pain and sensorimotor symptoms
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.
Time frame: Study visit and surgery
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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