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

Not Applicable

Active, not recruiting

• Conditions: Thoracic Neoplasms; Spine Metastases; Thoracic Cancer; Spine Cancer; Thoracic Diseases; Spine Disease
• Interventions: Diagnostic Test: MRI with custom MRI spine coil

• Registration Number: NCT04227717
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-01-09
• Study Completion: 2025-01-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic, lumbar and sacral spine lesions	MRI with custom MRI spine coil	Participants will have thoracic, lumbar and sacral spine lesions

Primary Outcome Measures

Name	Time	Method
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure	6 months	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States