Clinical trial NCT02888119: Imaging Biomarkers of Knee Osteoarthritis
Official title: Imaging Biomarkers of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to develop, evaluate and translate highly accelerated imaging sequences (each protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical 3T scanner using novel compression sensing and parallel imaging strategies.The overarching objective of the study is to establish a non-invasive imaging biomarker based on the development of rapid relaxation mapping with compressed sensing (CS) that will be clinically useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients with high risk of developing knee osteoarthritis (OA), 30 patients with mild OA and 30 healthy controls will be accrued.

Detailed description: Current noninvasive imaging methods to evaluate knee joints include plain radiographs, computed tomography (CT), and clinical morphological magnetic resonance imaging (MRI) of joint structures. These techniques can only detect later-stage, macroscopic joint structural abnormalities that are irreversible and not amenable to early therapy. This study aims to develop highly accelerated imaging sequences for ex-vivo knee OA applications on a standard clinical 3T scanner using novel CS and parallel imaging (PI) strategies.

Eligibility criteria: Inclusion Criteria:

* Patients in the HJD OA database, ages 40-75 with high risk of developing OA as defined by:

  (i) KL score of 0 (ii) Knee pain present in at least 1 knee (iii) Normal radiographs, (iv) At least one abnormal clinical MR finding such as prior knee injury, overweight or traumatic bone marrow edema lesions
* Patients ages 40-75 with early OA as determined by KL scores 1-2
* Healthy controls in the HJD OA database (KL score 0, no knee pain, no meniscal or ligament tears)

Exclusion Criteria:

* Contraindications for MRIs (e.g. pacemakers, ferromagnetic vascular clips, metal implants, claustrophobia, etc).
* Subjects with any joint disease (example: Rheumatoid or inflammatory arthritis) other than knee OA, corticosteroid injections within the previous 3 months, and history of avascular necrosis, Paget's disease of bone, Wilson's disease, gout, total knee replacement (or plan for replacement within next 24 months).
* Major co-morbidities such as diabetes, mellitus, cancer, congestive heart failure and chronic infectious diseases.
* Alignment interventions such as insoles and knee braces
* Vulnerable patients will not be recruited for this study

Primary outcomes:
measure: Change From Baseline in T1ρ Relaxation Time
timeFrame: Baseline, Month 24
measure: Change From Baseline in T2 Relaxation Time
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
timeFrame: Baseline, Month 24
measure: Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
timeFrame: Baseline, Month 24
measure: Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
timeFrame: Baseline, 24 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Ravinder Regatte, MD
role: PRINCIPAL_INVESTIGATOR
References: