Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03546335
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Benjamin Franc, MD/MBA
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF, San Francisco, California

Status

Recruiting

Address

UCSF

San Francisco, California, 94107

Site Contact

I-Wei Wu

Katherine.wu@ucsf.edu

415-353-9437

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