Microsurgical Resection of Intramedullary Spinal Cord Metastases

Study Purpose

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients. The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively. Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients. The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment. Primary endpoint (analysed in surgically treated ISCM patients): Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability. Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):

- Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months.

This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0

- 18 points, with higher score values representing better functional outcome.

The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.

- Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA subscores) - Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) - Impairment Scale at 90 days, 6 and 12 months.

- Rate & type of complications at 90 days after treatment according to The Novel Therapy.

- Disability-Neurology Grade (TDN grade)16.

- Overall survival (in days)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients admitted to one of the participating centres and treated for ISCM.

- Available documentation of admission and postoperative status.

Exclusion Criteria:

- Patients under the age of 18

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06042946
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cantonal Hospital of St. Gallen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Martin N. Stienen, PD, MD
Principal Investigator Affiliation	Cantonal Hospital St. Gallen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Cord Metastasis, Spinal Cord Tumor Malignant Intramedullary, Functional Outcome, Radiotherapy; Complications, Spinal Cord Neoplasms

Arms & Interventions

Arms

: iscm_resection

-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy

: iscm_radiotherapy

-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM

Interventions

Procedure: - Microsurgical resection of ISCM

Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.

Contact a Trial Team

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International Sites

Saint Gallen, Switzerland

Status

Recruiting

Address

Cantonal Hospital St. Gallen, Neurosurgery

Saint Gallen, , 9000

Site Contact

Martin N. Stienen, PD, MD

[email protected]

+41714942183

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