Microsurgical Resection of Intramedullary Spinal Cord Metastases

Radiotherapy; Complications Clinical Trial

Official title:

Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042946
• Other study ID #: 2023-00292
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: Martin N. Stienen, PD, MD
• Phone: +41 71 494 2183
• Email: martin.stienen[@]kssg.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Outcome
• Neoplasm Metastasis
• Radiotherapy; Complications
• Spinal Cord Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen, Neurosurgery	Saint Gallen

Sponsors (11)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen	Insel Gruppe AG, University Hospital Bern, Kantonsspital Aarau, Kantonsspital Winterthur KSW, Klinikum rechts der Isar Technische Universität München, Luzerner Kantonsspital, Stanford University, University Hospital Muenster, University Hospital, Geneva, University Hospital, Zürich, University of Toronto

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 90 days after treatment initiation
Secondary	Functional outcome	modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy	at 3, 6 and 12 months after treatment initiation
Secondary	Neurological outcome	measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade = 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits	at 6 and 12 months after treatment initiation
Secondary	Rate & type of complications	Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity.; higher Grades indicate higher severity of complication	within 90 days after treatment initiation
Secondary	Functional outcome	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.	at 6 and 12 months after treatment initiation