Molecular imaging using 99mTc-maraciclatide for detection of joint inflammation in inflammatory arthritis
Whole-body imaging using 99mTc-Maraciclatide for rheumatoid and psoriatic arthritis
STUDY DESIGN: Cross-sectional Observational Imaging Study. This study includes a maximum of four research visits. All visits will occur at Leeds Teaching Hospitals Trust, Chapel Allerton Hospital or St James University Hospital. At separate visits post-screening and in a randomised visit order, all participants will undergo: 1) Whole body multi-joint contrast-enhanced MRI scan and Ultrasound scan 2) Whole-body multi-joint gamma scintigraphy imaging using 99mTc-Maraciclatide In addition, there is the option to take synovial biopsy samples from participants, which may occur during an additional visit. There will be a maximum of 14 days between MRI and 99mTc-Maraciclatide imaging visits. RECRUITMENT: In this study, individuals with Rheumatoid Arthritis and Psoriatic Arthritis will be recruited from routine clinics at Chapel Allerton Hospital. The IMAGE-IA research team members are embedded in NHS clinics and therefore form part of the direct care team. Other potential participants would be referred to the research team (by LTHT colleagues in NHS clinics) for initial review/approach. Screening: After the participant has had a chance to review the information sheet, and to discuss any queries with a study investigator, they will be asked to complete and sign a consent form, and will be allocated a unique study ID code. The research team will then perform the following routine checks to ensure that it is appropriate and safe for the participant to take part, some of which may be additional to regular care: • Blood tests (Liver Function Test [LFT], Urea and Electrolytes [U&E], Erythrocyte Sedimentation Rate [ESR], C-Reactive Protein [CRP], high-sensitivity CRP[hsCRP], Rheumatoid Factor [RF], anti-CCP Ab) • Pregnancy test (for females of childbearing potential, i.e. where the individual has had a menstrual period in the last 24 months and has not had a hysterectomy or surgical sterilisation) • Height and body mass • Medical history • Physical exam • Vital signs
1. Age > = 18 years old 2. The participant is able and willing to comply with all study procedures as described in the protocol 3. Is capable of understanding and signing an informed consent form 4. Prior diagnosis of Rheumatoid Arthritis (RA) as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria; or prior diagnosis of PsA according to the CASPAR criteria 5. Low, moderate or high disease activity as determined by DAS28 score (RA) or DAPSA score (PsA). Individuals in remission, as determined by DAS28 or DAPSA, will not be included.
1. The participant size or body mass is not compatible with imaging as determined by the investigator 2. The participant has a known allergy to or has had an adverse reaction to any components or excipients of Maraciclatide (99mTc) Injection 3. The participant is pregnant or currently breastfeeding, and are unwilling to stop breastfeeding for a minimum of 12 hours after the Maraciclatide (99mTc) Imaging visit 4. The participant has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with any of the study procedures that would deem the participant inappropriate for study participation 5. Participant with severe renal disease (eGFR < 45 ml/min/1.73m2) or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis 6. The participant has hepatic insufficiency as demonstrated by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of > 3 times the upper limit of normal 7. The participant has a known allergy or previous anaphylactic reaction to a gadolinium-based contrast agent 8. The participant has: a pacemaker, surgical clips within the head*, certain inner ear implants, or neuro-electrical stimulators or metal fragments within the eye or head 9. The participant has any other known contraindication, in the opinion of the investigator, to contrast-enhanced MRI imaging 10. The participant that has one of the following joints unavailable for imaging (e.g. due to injury, joint-replacement, or missing joints): shoulder, wrist, MCP, PIP, knee, ankle, MTP 11. The participant has received any radiopharmaceutical within 7 days or 10 half-lives before screening 12. The participant has received intramuscular or intravenous steroids < = 4 weeks before screening 13. The participant has received intra-articular corticosteroid injections < = 4 weeks before screening 14. The participant has a known i