PET MRI for Evaluation of Knee Osteoarthritis in Patients With Bilateral Knee OA

NCT03174080 | Unknown

• 1 other identifier: Assuta MC
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (Osteoarthritis) of the knee is a high prevalence in the population of people aged 60 years and over, when in some cases does not cause any discomfort or pain, and therefore not diagnosed. In addition, Radio graphic findings of the knee not fully compatible with the patient's symptoms, which resulted in errors in the interpretation and diagnosis. In this study, patients who suffer from two knees or unilateral pain, will take part. Participants will undergo a clinical examination, including evaluation of symptoms by an orthopedist and an X-ray imaging, which are part of the currently accepted medical diagnosis. Patients will perform PET-MRI test in order to assess whether PET MRI is a more efficient tool for active knee osteoarthritis diagnosis.

Conditions

Knee Osteoarthritis

Keywords

Positron-Emission; PET Scan Tomography

Outcome Measures

Primary Outcomes (1)

• correlation between SUV to clinical evaluation

  correlation between SUV PET vs. WOMAC and VAS pain scores.

  3 months - 1 year

Interventions

FDG (glucose labeled isotope of fluorine) RADIATION

Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will consist of 150 patients with bilateral or uniltarel knee pain with one of the knees having more symptoms than the other.

You may qualify if:

• All patients that are sent for knee MRI
• Patients over the age of 50 years old
• All patients will sign an informed consent for the study prior to the PET MRI
• Unilateral or Bilateral knee pain
• All patients were ambulatory pre-operatively, using no more then a single cane
• All patients had prior Weight Bearing AP x-rays and Lateral Radiogrphs

You may not qualify if:

• Non ambulatory patients
• History of knee arthroscopy or other surgery 1 year before the MRI
• Bone scan performed in the past 3 months prior to the PET MRI
• Clastrophobia

Sponsors & Collaborators

• Assuta Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

without biospecimen

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro. David Groshar

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: June 2, 2017
• Study Start: July 16, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share