Trial Outcomes & Findings for FDG PET/MRI Evaluation of Facet Joint Pain (NCT NCT02921490)

Results Overview

Concordance of high grade FDG scores with clinical impression

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

2 years

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	PET/MR Recipients All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Age, Continuous	63 years n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants
Number of patients with back pain	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 2 years

Concordance of high grade FDG scores with clinical impression

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint High Grade FDG Activity Concordance to Pain	0.10 concordance correlation coefficient

PRIMARY outcome

Timeframe: 2 years

Population: The measure is best reported in sides, which is 2 sides per patient. 10 patients with 20 sides.

Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=20 sides (left or right) All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint All Grades of FDG Activity Concordance to Pain	12 sides (left or right)

PRIMARY outcome

Timeframe: 2 years

Population: Two sides for each patient, for a total of 20 sides

Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint High Grade MRI Signal Change Concordance to Pain	12 sides (left or right)

PRIMARY outcome

Timeframe: 2 years

Population: two sides for each patient, for a total of 20 sides

Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint Any Grade of MRI Signal Change Concordance to Pain	12 sides (Left or Right)

PRIMARY outcome

Timeframe: 2 years

Number/percentage of subjects for whom high grade FDG scores would change clinical management

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint High Grade FDG Activity Potential Effect on Management	8 Participants

PRIMARY outcome

Timeframe: 2 years

Number/percentage of subjects for whom any grade FDG scores would change clinical management

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint All Grades of FDG Activity Potential Effect on Management	8 Participants

PRIMARY outcome

Timeframe: 2 years

Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint High Grade MRI Signal Change Potential Effect on Management	8 Participants

PRIMARY outcome

Timeframe: 2 years

Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management

Outcome measures

Outcome measures
Measure	PET/MR Recipients n=10 Participants All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint Any Grade MRI Signal Change Potential Effect on Management	8 Participants

Adverse Events

PET/MR Recipients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PET/MR Recipients n=10 participants at risk All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Blood and lymphatic system disorders IV site swelling	10.0% 1/10 • Number of events 1 • 1 year No serious adverse events have been reported. No one is suspected to have a serious adverse event.

Additional Information

Vance Lehman

Mayo Clinic

Phone: 1-507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place