Cancer PainCORD-MRINCT07400055
MRI Evaluation of Spinal Cord Edema After CT-Guided Percutaneous Cordotomy in Cancer Pain Patients
An observational study of Cancer Pain and Intractable Pain, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Intractable Pain, Spinal Cord Edema
- What is being tested?
- CT-guided Percutaneous Cervical Cordotomy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with intractable cancer-related pain undergoing routine CT-guided percutaneous cervical cordotomy at a tertiary university hospital pain clinic. Participants will be followed prospectively with postoperative MRI and clinical assessments.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Department of Algology
Mersin, Yenişehir, 33110
Mesut Bakır, Assoc. Prof., +90 545 745 06 55, mesutbakir@mersin.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Pain, Intractable Pain, Spinal Cord Edema, Neuropathic Pain
- Being tested
- CT-guided Percutaneous Cervical Cordotomy
- Keywords
- Percutaneous Cordotomy, CT-guided Cordotomy, Cervical Cordotomy, Spinal Cord MRI, Radiofrequency Ablation, Postprocedural Complications
- Medical subject headings
- Cancer Pain, Pain, Intractable, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Percutaneous Cervical CordotomyProcedure or surgery
Routine clinical percutaneous cervical cordotomy performed under CT guidance using radiofrequency ablation at the C1-C2 level for the treatment of intractable cancer pain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CT-guided Percutaneous Cervical Cordotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy
Spinal cord edema will be evaluated on cervical MRI by a single radiologist, including presence, location, and longitudinal extent of edema.
Measured: Postoperative day 1 and 1 month
Secondary outcomes (1)
Change in pain intensity measured by Numeric Rating Scale (NRS)
Pain severity will be assessed using a 0-10 numeric rating scale.
Measured: Baseline, postoperative day 1, and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Bakır, Mersin University
- Investigators
- Mesut Bakır, Principal investigator, Mersin University Faculty of Medicine, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400055
- Sponsor's protocol ID
- CORD-MRI-2026
- Acronym
- CORD-MRI
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. Data will be used solely for the purposes of this study and reported in aggregate form.
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.
PubMed 23344872Mercadante 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.
PubMed 32434924Zomers 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.
PubMed 33350042
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07400055
- Acronym / sponsor ID
- CORD-MRI / CORD-MRI-2026
- Conditions
- Cancer Pain, Intractable Pain, Spinal Cord Edema, Neuropathic Pain
- Keywords
- Percutaneous Cordotomy, CT-guided Cordotomy, Cervical Cordotomy, Spinal Cord MRI, Radiofrequency Ablation, Postprocedural Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 Feb 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Cervical Cordotomy Cohort | – | Procedure: CT-guided Percutaneous Cervical CordotomyAdult patients with cancer-related pain undergoing routine CT-guided percutaneous cervical cordotomy and followed with postoperative MRI and clinical assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with intractable cancer-related pain undergoing routine CT-guided percutaneous cervical cordotomy at a tertiary university hospital pain clinic. Participants will be followed prospectively with postoperative MRI and clinical assessments.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CT-guided Percutaneous Cervical CordotomyRoutine clinical percutaneous cervical cordotomy performed under CT guidance using radiofrequency ablation at the C1-C2 level for the treatment of intractable cancer pain. | Procedure or surgery | Percutaneous Cervical Cordotomy Cohort |
Primary outcome
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.
1 secondary outcome
Change in pain intensity measured by Numeric Rating Scale (NRS)
Time frame: Baseline, postoperative day 1, and 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 23344872Kanpolat 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.
- Background: PubMed 32434924Mercadante 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.
- Background: PubMed 33350042Zomers 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. Data will be used solely for the purposes of this study and reported in aggregate form.
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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.
Mesut Bakır principal investigator
Mersin University Faculty of Medicine, Pain Clinic
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 Cancer Pain and Intractable Pain, run by Mersin University at 1 site in Turkey (Türkiye).
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 5 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: opening soon, as of the sponsor's last update on 10 Feb 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mesut Bakır, Assoc.Prof (+905457450655, mesutbakir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy (time frame: Postoperative day 1 and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400055, which also lists 3 linked publications.
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 10 Feb 2026.