Mersin University Faculty of Medicine, Department of Algology
Mersin, Yenişehir, 33110, Turkey (Türkiye)
NCT Number: NCT07400055
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Mersin, Yenişehir, 33110, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Routine clinical percutaneous cervical cordotomy performed under CT guidance using radiofrequency ablation at the C1-C2 level for the treatment of intractable cancer pain.
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.
Time frame: Baseline, postoperative day 1, and 1 month
Pain severity will be assessed using a 0-10 numeric rating scale.
Contact information is provided by the study sponsor or research team.
Mersin University
Other
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
Acronym: CORD-MRI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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