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Trial Title:
3T MRI of Intramedullary Spinal Cord Tumours
NCT ID:
NCT05664438
Condition:
Spinal Cord Tumor of Cervical Spine
Conditions: Official terms:
Spinal Cord Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRI scan
Description:
MRI scan of cervical spine
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
John Radcliffe Hospital
Address:
City:
Oxford
Zip:
OX3 9DU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jessica Walsh, PhD
Email:
jessica.walsh@ndcn.ox.ac.uk
Start date:
October 17, 2022
Completion date:
October 1, 2023
Lead sponsor:
Agency:
University of Oxford
Agency class:
Other
Source:
University of Oxford
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05664438