MRI Evaluation of Spinal Cord Edema After CT-Guided Percutaneous Cordotomy in Cancer Pain Patients

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

Overview

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.

Interventions

• Procedure CT-guided Percutaneous Cervical Cordotomy
  Routine clinical percutaneous cervical cordotomy performed under CT guidance using radiofrequency ablation at the C1-C2 level for the treatment of intractable cancer pain.

Primary outcome measures

• Presence and extent of spinal cord edema on cervical MRI after CT-guided percutaneous cordotomy [Time frame: Postoperative day 1 and 1 month]

Secondary outcome measures (1)

• Change in pain intensity measured by Numeric Rating Scale (NRS) [Time frame: Baseline, postoperative day 1, and 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Mersin University Faculty of Medicine, Department of Algology — Mersin

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. PMID 23344872
• 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. PMID 32434924
• 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. PMID 33350042

Identifiers

NCT: NCT07400055 · CORD-MRI-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗