Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine

Thoracic Diseases Clinical Trial

Official title:

Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04227717
• Other study ID #: 19-476
• Status: Active, not recruiting
• Start date: January 9, 2020
• Est. completion date: January 9, 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: January 9, 2025
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >/= 18 years of age at the time of treatment
• Able to give informed consent
• Consented for spine stereotactic radiation therapy
• No contraindications for CT myelograms which include:
• Allergy to CT contrast
• Use of phenothiazines
• Platelet count < 60,000 K/mcl
• INR > 1.5
• VEGF inhibitor use in the past 2 weeks prior to myelogram
• NSAID use in the past 5 days prior to myelogram
• Renal disease
• Creatinine > 1.2 mg/dL
• No contraindications for MRI scans which include:
• Newly placed glucose monitors
• Tattoos (Tattoos for radiation therapy are allowed)
• Presence of a cardiac pacemaker
• Presence of an implanted cardioverter defibrillator
• Breast tissue expander
• Aneurysm clip
• Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
• Severe claustrophobia or inability to lie flat for the duration of the study, etc.

Exclusion Criteria:

• Presence of surgical spine hardware at the region of interest
• Presence of cervical spine lesions
• History of claustrophobia

Related Conditions & MeSH terms

• Spinal Diseases
• Spine Cancer
• Spine Disease
• Spine Metastases
• Thoracic Cancer
• Thoracic Diseases
• Thoracic Neoplasms

Intervention

Diagnostic Test:
• MRI with custom MRI spine coil
Participants will undergo MRI with custom MRI spine coil

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure	The calculated doses to the cauda equine and spinal cord will be compared and evaluated for significant difference based upon the imaging modality (MRI coil vs CT myelogram) used to define each structure, with all other target and avoidance volumes being equal in the same patient.	6 months

External Links

•   Memorial Sloan Kettering Cancer Center