Spinal Cord Tumor of Cervical SpineNCT05664438
3T MRI of Intramedullary Spinal Cord Tumours
An observational study of Spinal Cord Tumor of Cervical Spine, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Tumor of Cervical Spine
- What is being tested?
- MRI scan
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Jessica Walsh, PhD, jessica.walsh@ndcn.ox.ac.uk
About this study
Official title: Multimodal MRI to Differentiate Subtypes of Intramedullary Spinal Cord Tumours: A Pilot Study
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.
Read more
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.
- Conditions
- Spinal Cord Tumor of Cervical Spine
- Being tested
- MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
MRI scan of cervical spine
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study visit
Secondary outcomes (2)
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.
Measured: 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.
Measured: Study visit and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start17 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Tumor of Cervical SpineStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664438
- Sponsor's protocol ID
- 15346
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal MRI to Differentiate Subtypes of Intramedullary Spinal Cord Tumours: A Pilot Study
- ClinicalTrials.gov ID
- NCT05664438
- Acronym / sponsor ID
- 15346
- Conditions
- Spinal Cord Tumor of Cervical Spine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanMRI scan of cervical spine | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Determine the added value of advanced MRI features to identify the spinal cord posterior midline
Time frame: Study visit and surgery
Investigate the relationship between MRI metrics and patient pain and sensorimotor symptoms
Time frame: Study visit and surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Tumor of Cervical Spine, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Walsh, PhD (01865 611450, jessica.walsh@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate whether advanced MRI can differentiate between tumour subtypes confirmed by histopathology from biopsy (time frame: Study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.