NCT07400055

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Percutaneous CordotomyCT-guided CordotomyCervical CordotomySpinal Cord MRIRadiofrequency AblationPostprocedural Complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative day 1 and 1 month

Secondary Outcomes (1)

  • Change in pain intensity measured by Numeric Rating Scale (NRS)

    Baseline, postoperative day 1, and 1 month

Study Arms (1)

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.

Procedure: CT-guided Percutaneous Cervical Cordotomy

Interventions

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

Percutaneous Cervical Cordotomy Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Medicine, Department of Algology

Mersin, Yenişehir, 33110, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 23344872BACKGROUND
  • 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: 32434924BACKGROUND
  • 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: 33350042BACKGROUND

MeSH Terms

Conditions

Cancer PainPain, IntractableNeuralgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Mesut Bakır

    Mersin University Faculty of Medicine, Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesut Bakır, Assoc.Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Algology

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations