- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400055
MRI Evaluation of Spinal Cord Edema After CT-Guided Percutaneous Cordotomy in Cancer Pain Patients (CORD-MRI)
Evaluation of Medulla Spinalis Edema After CT-Guided Percutaneous Cervical Cordotomy Using Magnetic Resonance Imaging and Its Association With Postprocedural Clinical Outcomes in Patients With Cancer Pain
This observational study aims to evaluate changes in the spinal cord following CT-guided percutaneous cervical cordotomy performed for the treatment of intractable cancer-related pain. Cordotomy is a routine clinical procedure used to relieve severe pain in selected cancer patients. After the procedure, some patients may develop temporary neurological symptoms that are thought to be related to spinal cord edema.
In this study, magnetic resonance imaging (MRI) will be performed as part of routine clinical follow-up on postoperative day 1 and at 1 month to assess the presence and extent of spinal cord edema. Clinical outcomes, including pain intensity and possible postprocedural symptoms, will be recorded and compared with MRI findings.
The goal of this research is to better understand the relationship between imaging changes in the spinal cord and clinical outcomes after cordotomy, which may help improve patient care and postoperative management in the future.
Study Overview
Status
Intervention / Treatment
Detailed Description
Percutaneous cervical cordotomy is a well-established palliative procedure used for the management of severe unilateral cancer-related pain that is refractory to medical treatment. The procedure involves CT-guided placement of a radiofrequency electrode at the C1-C2 level to create a lesion in the anterolateral spinothalamic tract, resulting in effective pain relief. Despite its efficacy, transient neurological effects such as dysesthesia, sensory disturbances, and neuropathic pain may occur following the procedure. These clinical findings are believed to be associated with postoperative changes in the spinal cord, including edema.
This prospective observational study is designed to evaluate the presence and extent of medulla spinalis edema following CT-guided percutaneous cervical cordotomy and to investigate its association with clinical outcomes.
A total of 10 to 15 adult patients with cancer-related pain who undergo cordotomy as part of routine clinical care at Mersin University Faculty of Medicine Algology Clinic will be enrolled. Eligible patients will be those aged 18 years or older with an indication for cordotomy.
All procedures will be performed under CT guidance at the C2 level using radiofrequency ablation with standard clinical parameters. No additional interventions will be applied for research purposes.
Clinical assessments will include baseline pain intensity measured using a numeric rating scale (NRS), postoperative pain scores, and evaluation of potential neurological symptoms such as dysesthesia, sensory loss, and other transient complications.
Cervical MRI will be performed as part of routine follow-up on postoperative day 1 and at 1 month. MRI images will be evaluated by a single experienced radiologist who will assess the presence, location, and extent of spinal cord edema and any additional structural changes.
The primary objective is to determine the frequency and characteristics of spinal cord edema following cordotomy as detected by MRI. Secondary objectives include evaluating the relationship between MRI findings and postoperative clinical symptoms as well as changes in pain intensity.
All collected data will be analyzed descriptively and through correlation analyses to explore associations between imaging findings and clinical outcomes.
This study aims to provide a better understanding of postoperative spinal cord changes after cordotomy and their clinical significance, potentially contributing to improved patient selection, monitoring, and management strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mesut Bakır, Assoc.Prof
- Phone Number: +905457450655
- Email: mesutbakir@gmail.com
Study Locations
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Yenişehir
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Mersin, Yenişehir, Turkey (Türkiye), 33110
- Mersin University Faculty of Medicine, Department of Algology
-
Contact:
- Mesut Bakır, Assoc. Prof.
- Phone Number: +90 545 745 06 55
- Email: mesutbakir@mersin.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adults aged 18 years and older
Patients with cancer-related pain refractory to medical treatment
Patients scheduled to undergo CT-guided percutaneous cervical cordotomy as part of routine clinical care
Ability to provide informed consent
Availability for postoperative MRI follow-up on day 1 and at 1 month
Exclusion Criteria:
Patients younger than 18 years
Patients without an indication for percutaneous cervical cordotomy
Inability to undergo MRI (e.g., incompatible implants, severe claustrophobia)
Patients who decline participation or withdraw consent
Incomplete clinical or imaging follow-up data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Percutaneous Cervical Cordotomy Cohort
Adult patients with cancer-related pain undergoing routine CT-guided percutaneous cervical cordotomy and followed with postoperative MRI and clinical assessments.
|
Routine clinical percutaneous cervical cordotomy performed under CT guidance using radiofrequency ablation at the C1-C2 level for the treatment of intractable cancer pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy
Time Frame: Postoperative day 1 and 1 month
|
Spinal cord edema will be evaluated on cervical MRI by a single radiologist, including presence, location, and longitudinal extent of edema.
|
Postoperative day 1 and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity measured by Numeric Rating Scale (NRS)
Time Frame: Baseline, postoperative day 1, and 1 month
|
Pain severity will be assessed using a 0-10 numeric rating scale.
|
Baseline, postoperative day 1, and 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mesut Bakır, Mersin University Faculty of Medicine, Pain Clinic
Publications and helpful links
General Publications
- Kanpolat Y, Ozdemir M, Al-Beyati E. CT-guided percutaneous cordotomy for intractable pain in what is more than a disease: lung malignancies. Turk Neurosurg. 2013;23(1):81-7. doi: 10.5137/1019-5149.JTN.6980-12.0.
- Mercadante S. Intractable pain and cordotomy. BMJ Support Palliat Care. 2020 Sep;10(3):339. doi: 10.1136/bmjspcare-2020-002360. Epub 2020 May 20. No abstract available.
- Zomers PJW, Groeneweg G, Baart S, Huygen FJP. Percutaneous Cervical Cordotomy for the Treatment of Cancer Pain: A Prospective Case Series of 52 Patients with a Long-Term Follow-Up. Pain Pract. 2021 Jun;21(5):557-567. doi: 10.1111/papr.12991. Epub 2021 Jan 22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORD-MRI-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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