5515: VCRC Imaging Protocol for Magnetic Resonance and Positron Emission Tomography in Large-Vessel Vasculitis (Takayasu's Arteritis): Development as Clinical Trial Outcome Measures

Status: Recruiting

Background

Takayasu's arteritis is a rare disease that affects the blood vessels. Takayasu's arteritis can cause swelling of large and medium-sized blood vessels. The blood vessels that are commonly affected are the branches of the aorta (the main blood vessel that leaves the heart). The purpose of this study is to help doctors learn more about this disease by using x-ray-like tests to see if they are helpful in taking care of patients with Takayasu’s arteritis.

About this Study

This is an imaging study that compares x-ray-like tests that would not be a part of your regular care (PET/CT) with x-ray-like tests that are a part of your regular care (MRI). At two visits, three months apart, patients will have a PET/CT scan performed at the same time as their MRI scan; some patients with also have a third PET/CT scan. A total of 36 people with Takayasu's arteritis at several hospitals will take part in this study. Doctors will use images from the different time points, along with information from exams and symptoms, to learn more about the disease.

Target Enrollment

To be eligible to participate, you must:

  1. Have a diagnosis of Takayasu’s arteritis as defined by the VCRC Longitudinal Study 5503: Longitudinal Protocol for Takayasu's Arteritis and be enrolled in the VCRC Longitudinal Study 5503 at the same time.
  2. Be older than 16 years of age.
  3. Have active disease occurring in combination with a disease relapse within 2 weeks before enrollment.

    Active disease will be defined by the presence of clinical features or imaging or both:

    Clinical features:
    • Constant fever higher than 38° C for longer than 1 week
    • Blood vessel pain/tenderness, scalp tenderness, or an abnormal blood vessels of the head
    • Unusual headaches
    • Limit of blood supply to the eye (retina), damage to the eye nerve, or loss of vision
    • Tongue/jaw pain and/or cramping
    • Brief limit of blood supply in the brain or stroke
    • Pain and/or cramping in body limbs
    • Muscle and bone symptoms (joint swelling or morning stiffness)
    • General feeling of being unwell and tired
    • Other symptoms/signs known by the doctor to be related Takayasu’s arteritis
       
  4. Willing and able to follow the imaging schedule and follow-up procedures
  5. Willing and able to give informed consent

You are not eligible to participate if:

  1. You are pregnant or breast feeding 
  2. You are not able to follow study rules
  3. You are not able to safely have an MRI scan

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

United States

  • Boston University School of Medicine, Boston, MA
    Naomi Amudala
    Study Coordinator
    E-mail: namudala@bu.edu
    Phone: 617-358-6796
     
  • Cleveland Clinic Foundation, Cleveland, Ohio
    Elizabeth Kisela
    Study Coordinator
    E-mail: kiselae@ccf.org
    Phone: 216-444-4887
     
  • Mayo Clinic College of Medicine, Rochester, MN
    Jane Jaquith
    Study Coordinator
    E-mail: jaquith.jane@mayo.edu
    Phone: 507-284-4502

Canada

  • St. Joseph's Healthcare, Hamilton, ON
    Sandra Messier, RCT
    Vascular Medicine Research Coordinator
    E-mail: smessier@stjoes.ca
    Phone: 905-522-1155 Ext. 33260
     
  • University of Toronto Mount Sinai Hospital, Toronto
    Masoomeh Ashrafi
    Study Coordinator
    E-mail: MAshrafi@mtsinai.on.ca
    Phone: 416-586-4800 Ext. 6754