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Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

Sponsor
Robert Flavell, MD, PhD (Other)
Overall Status
Suspended
CT.gov ID
NCT03546335
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
66
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1mCi injection of 89Zr-DFO-CZP

The first 2 patients will receive 1mCi of 89Zr-DFO-CZP.

Drug: 89Zr-DFO-CZP
89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
Other Names:
  • 89Zr-Cimzia

    		•
    Experimental: 0.5mCi injection 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.

    Drug: 89Zr-DFO-CZP
    89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
    Other Names:
  • 89Zr-Cimzia

    		•
    Experimental: 1.5mCi injection 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.

    Drug: 89Zr-DFO-CZP
    89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
    Other Names:
  • 89Zr-Cimzia

    		•
    Experimental: 2mCi injection 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.

    Drug: 89Zr-DFO-CZP
    89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
    Other Names:
  • 89Zr-Cimzia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA). [2 years]

      Investigators will be evaluating whether 89Zr-DFO-CZP is taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).

    Secondary Outcome Measures

    1. Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic. [2 years]

      Investigators will be evaluating the uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age > 18 years old

    2. Ability to read and understand written informed consent document

    3. Patients with clinical diagnosis of rheumatoid arthritis

    Exclusion Criteria:

    1. For patients planning to be imaged on PET (positron emission tomography) / MRI (magnetic resonance imaging) (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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • Robert Flavell, MD, PhD

    Investigators

    • Principal Investigator: Robert Flavell, MD, PhD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Flavell, MD, PhD, Assistant Professor in Residence, University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03546335
    Other Study ID Numbers:
    • 17-23566
    First Posted:
    Jun 6, 2018
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jun 10, 2022