Imaging with a novel radioactive tracer called 99mTc-Maraciclatide to detect inflammation in the joint in individuals with arthritis
- Conditions
- Whole-body imaging using 99mTc-Maraciclatide for rheumatoid and psoriatic arthritisMusculoskeletal Diseases
- Registration Number
- ISRCTN13161614
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 68
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 inability to manage pain effectively with alternative forms of analgesia to NSAIDs (e.g. Paracetamol, Codeine)
*X-ray may be requested if there is a need to confirm/exclude the presence of surgical clips or metal fragments in the eye/head.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Individual site (enthesis/tendon/joint) inflammation (synovitis) measured by 99mTc-Maraciclatide present Y/N (0 absent, 1 present) at one time point
- Secondary Outcome Measures
Name Time Method