Zr-89 Cimzia PET Imaging Rheumatoid Arthritis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/13/2018 |
Start Date: | October 1, 2018 |
End Date: | April 1, 2020 |
Contact: | I-Wei Wu |
Email: | Katherine.wu@ucsf.edu |
Phone: | 415-353-9437 |
Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis
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.
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.
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.
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.
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-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.
We found this trial at
1
site
1635 Divisadero Street
San Francisco, California 94143
San Francisco, California 94143
Principal Investigator: Benjamin Franc, MD
Phone: 415-353-9437
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