Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Robert Flavell, MD/PhD (ucsf)
Photo of Robert Flavell
Robert Flavell

Description

Summary

This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.

Official Title

Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis

Details

This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging. Study 1 is a dose finding study that will involve a single 89Zr-DFO-CZP PET scan acquired ~24 hours following a single administration of the radiopharmaceutical. The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. After receiving the dose, participants will undergo 4 serial whole body PET scans between 2 hours and 120 hours after dose administration. Several blood samples will also be collected over this time period, for dosimetry analysis.

Keywords

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid 89Zr-DFO-CZP

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age > 18 years old
  2. Ability to read and understand written informed consent document
  3. Patients with clinical diagnosis of rheumatoid arthritis

You CAN'T join if...

  1. For patients planning to be imaged on PET-MR scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia
  2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
  3. Patients who have had a study involving radiation within one year of enrolling in this study
  4. Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
  5. Patients who are breastfeeding
  6. Patients who cannot confirm that they will use reliable contraceptive methods for 90 days
  7. Patients treated with TNF - α inhibitor therapy
  8. Females of child-bearing age (<50 years old), until data from the dose-finding study has been reviewed by the UCSF Radiation Safety Committee and explicit written permission has been provided by the UCSF Radiation Safety Committee to open the window of potential female participants to ages 18 years and older.

Location

  • UCSF
    San Francisco California 94107 United States

Lead Scientist at UC Health

  • Robert Flavell, MD/PhD (ucsf)
    Robert Flavell, MD, PhD, is the Chief of Molecular Imaging and Therapeutics Clinical Section in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. He received his medical degree from Weill Cornell Medical College, and his PhD from the Rockefeller University as part of the Tri-Institutional MD PhD program.

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Robert Flavell, MD, PhD
ID
NCT03546335
Phase
Phase 1
Study Type
Interventional
Last Updated