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Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

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ClinicalTrials.gov Identifier: NCT04248543
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.

Condition or disease Intervention/treatment Phase
Spinal Metastases Device: qMRI with Gadoteridol contrast agent Not Applicable

Detailed Description:
Metastatic spine disease (MSD) can result in considerable morbidity from pain, spinal cord compromise and neurologic disability. Recent developments in image-guidance and immobilization have enabled more accurate target localization, which allows methods of precise high-dose radiation delivery such as stereotactic body radiation therapy (SBRT). SBRT carries potential risks of radiation induced myelopathy (RIM) and vertebral compression fracture (VCF). Magnetic resonance imaging (MRI) is a sensitive imaging modality that may be able to detect radiation-induced damage in the vertebral body or spinal cord following SBRT. Quantitative MR-based imaging methods may also help to quantify treatment response and help predict subsequent outcomes such as tumor control and VCF risk.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gadoteridol

Arms and Interventions
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Arm Intervention/treatment
Experimental: quantitative MRI at 4 weeks Device: qMRI with Gadoteridol contrast agent
quantitative MR: MRI uses a magnet and radio waves to make medical images of the body. Gadoteridol is used as a contrast agent. Quantitative MRI involves the use of software to analyze the acquired images.
Other Name: quantitative MRI


Outcome Measures
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Primary Outcome Measures :
  1. Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI) [ Time Frame: baseline, 4 wks ]
  2. Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI) [ Time Frame: baseline, 4 wks ]
  3. Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI [ Time Frame: baseline, 4 wks ]

Secondary Outcome Measures :
  1. Change in numeric pain score as measured by the Numeric Pain Rating Scale [ Time Frame: baseline, 4 wks ]
    Measured from 0-10 with 0 being no pain and 10 being severe pain

  2. Change in numeric pain score as measured by the Brief Pain Inventory [ Time Frame: baseline, 4 wks ]
    Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain

  3. Change in numeric pain score as measured by the EQ5D Pain Questionnaire [ Time Frame: baseline, 4 wks ]
    Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain

  4. Change in opioid use [ Time Frame: baseline, 4 wks ]
  5. Change in quality of life as measured by the Pat Sf36 V2 assessment [ Time Frame: baseline, 4 wks ]
    Pat SF36 V2 is a quality of life survey about physical activity, general health and daily functions measured from excellent/much better/yes, limited a lot/all of the time/not at all, through poor/much worse/no,not limited at all/none of the time/extremely with additional not answered option

  6. Change in quality of life as measured by the PROMIS assessment [ Time Frame: baseline, 4 wks ]
    PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much.

  7. Change in quality of life as measured by the SOSG+ assessment [ Time Frame: baseline, 4 wks ]
    Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of metastatic cancer with a vertebral body metastasis or contiguous vertebral body metastases for which SBRT is appropriate
  • Age ≥ 18 years of age
  • KPS ≥ 70
  • Life expectancy of at least 3 months
  • No contraindication to undergoing MR imaging
  • Serum creatinine must be measured within 7 days prior to the research MRI with GFR >/= 30 mL/min2
  • Women of childbearing age must have a negative serum pregnancy test to meet eligibility per Duke Policy
  • Pre-treatment pain score of at least 3/10 based on the numeric pain rating scale (NPRS)
  • Disease located from C1 to L2

Exclusion Criteria:

  • Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia)
  • Vertebral body metastasis from L3-sacrum where spinal cord is no longer apparent
  • Subjects with prior radiation to the involved vertebral body
  • Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
  • Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed
  • Pregnant or breast-feeding women
  • Allergy to standard IV contrast agents used in MRI
  • Subjects with eGFR <30 30 mL/min2 or on dialysis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248543


Contacts
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Contact: Jennifer Mewshaw, NP 919 668 5211 jennifer.mewshaw@duke.edu

Locations
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United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Tykeytra Dale, BSN MS    919-668-3726      
Contact: Jennifer Mewshaw, NP    919 668 5211      
Principal Investigator: Scott Floyd, MD PhD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Scott Floyd, MD PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04248543    
Other Study ID Numbers: Pro00103960
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Duke University:
Vertebral compression fracture
Radiation induced myelopathy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes