Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

Robert Flavell, MD, PhD

Status and phase: Suspended; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: 89Zr-DFO-CZP

Study type: Interventional

Funder types: Other

Identifiers

NCT03546335

17-23566

Details and patient eligibility

About

This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (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.

Full 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 rheumatoid arthritis (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 millicurie (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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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-alpha 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 design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

1 mCi injection of 89Zr-DFO-CZP

Experimental group

Description:

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

Treatment:

Drug: 89Zr-DFO-CZP

0.5 mCi injection of 89Zr-DFO-CZP

Experimental group

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.

Treatment:

Drug: 89Zr-DFO-CZP

1.5 mCi injection of 89Zr-DFO-CZP

Experimental group

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.

Treatment:

Drug: 89Zr-DFO-CZP

2 mCi injection of 89Zr-DFO-CZP

Experimental group

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.

Treatment:

Drug: 89Zr-DFO-CZP