Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

Spinal Metastases Clinical Trial

Official title:

Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248543
• Other study ID #: Pro00103960
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Taylor Fryman, BS
• Phone: (919) 668-3726
• Email: taylor.fryman[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Women of childbearing age must have a negative urine or serum pregnancy test to meet eligibility per Duke Policy

• Pre-treatment pain score of at least 1/10 based on the numeric pain rating scale (NPRS)

• Disease located from C1 to S5

• Subjects with prior radiation to the involved vertebral body are allowed.

Exclusion Criteria:

• Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia)

• 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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)		baseline, 4 wks
Primary	Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)		baseline, 4 wks
Primary	Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI		baseline, 4 wks
Secondary	Change in numeric pain score as measured by the Numeric Pain Rating Scale	Measured from 0-10 with 0 being no pain and 10 being severe pain	baseline, 4 wks
Secondary	Change in numeric pain score as measured by the Brief Pain Inventory	Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain	baseline, 4 wks
Secondary	Change in numeric pain score as measured by the EQ5D Pain Questionnaire	Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain	baseline, 4 wks
Secondary	Change in opioid use		baseline, 4 wks
Secondary	Change in quality of life as measured by the Pat Sf36 V2 assessment	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	baseline, 4 wks
Secondary	Change in quality of life as measured by the PROMIS assessment	PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much.	baseline, 4 wks
Secondary	Change in quality of life as measured by the SOSG+ assessment	Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much	baseline, 4 wks