Back to resultsZr-89 Cimzia PET Imaging Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
89Zr-DFO-CZP
Sponsored by
About this trial
This is an interventional diagnostic trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years old
- Ability to read and understand written informed consent document
- Patients with clinical diagnosis of rheumatoid arthritis
Exclusion Criteria:
- 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
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
- Patients who have had a study involving radiation within one year of enrolling in this study
- 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)
- Patients who are breastfeeding
- Patients who cannot confirm that they will use reliable contraceptive methods for 90 days
- Patients treated with TNF - α inhibitor therapy
- 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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1mCi injection of 89Zr-DFO-CZP
0.5mCi injection of 89Zr-DFO-CZP
1.5mCi injection of 89Zr-DFO-CZP
2mCi injection of 89Zr-DFO-CZP
Arm Description
The first 2 patients will receive 1mCi 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.
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.
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.
Outcomes
Primary Outcome Measures
Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
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
Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03546335
Brief Title
Zr-89 Cimzia PET Imaging Rheumatoid Arthritis
Official Title
Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Suspended
Why Stopped
Lapse in study funding.
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Flavell, MD, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1mCi injection of 89Zr-DFO-CZP
Arm Type
Experimental
Arm Description
The first 2 patients will receive 1mCi of 89Zr-DFO-CZP.
Arm Title
0.5mCi injection of 89Zr-DFO-CZP
Arm Type
Experimental
Arm Description
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.
Arm Title
1.5mCi injection of 89Zr-DFO-CZP
Arm Type
Experimental
Arm Description
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.
Arm Title
2mCi injection of 89Zr-DFO-CZP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
89Zr-DFO-CZP
Other Intervention Name(s)
89Zr-Cimzia
Intervention Description
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).
Primary Outcome Measure Information:
Title
Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
Description
Investigators will be evaluating whether 89Zr-DFO-CZP is taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years old
Ability to read and understand written informed consent document
Patients with clinical diagnosis of rheumatoid arthritis
Exclusion Criteria:
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
Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
Patients who have had a study involving radiation within one year of enrolling in this study
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)
Patients who are breastfeeding
Patients who cannot confirm that they will use reliable contraceptive methods for 90 days
Patients treated with TNF - α inhibitor therapy
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Flavell, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Zr-89 Cimzia PET Imaging Rheumatoid Arthritis
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