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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Tim
Hardy
+44 (0)113 3924396
t.hardy@leeds.ac.uk
Dr
Kulveer
Mankia
+44 (0)113 3924396
K.S.Mankia@leeds.ac.uk
Whole-body imaging using 99mTc-Maraciclatide for rheumatoid and psoriatic arthritis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA) are autoimmune diseases that cause inflammation in joints. Over time, if the inflammation is not treated, it can cause permanent joint damage, disability and impaired quality of life. It is now known that in RA and PsA, starting treatment earlier in the course of the disease can improve long-term outcomes. Imaging techniques such as ultrasound (US) and magnetic resonance imaging (MRI) can help identify joint inflammation in individuals with RA and PsA, to understand the best treatment to use. Both techniques tend to focus on specific joints rather than assessing inflammation in the whole body. In addition, MRI is expensive, not always readily accessible, and is incompatible with pacemakers and other metallic implants. Therefore, other imaging techniques able to detect joint inflammation at the whole body level are required. The purpose of this study is to understand whether a whole-body imaging technique called gamma scintigraphy, using a very small amount of radioactive material (a radiotracer called Technetium-99m Maraciclatide), can help detect inflammation in and around the joint in individuals with RA and PsA, and to compare the results to established imaging techniques. A UK company, called Serac Healthcare Ltd is in the late stages of developing 99mTc-maraciclatide which has been designed to be attracted to cells within inflamed joints. When the tracer is added to a very small dose of radiation (an amount similar to a standard chest CT scan) it is expected to help imaging specialists and other doctors to see inflamed joints. So far, the radiotracer (99mTc-maraciclatide) has been given to 25 healthy volunteers and over 130 patients. There have been no harmful side effects. It was also shown that the scan could make it easier for doctors to see inflamed joints.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. The participant size or body mass is not compatible with imaging as determined by the investigator2. The participant has a known allergy to or has had an adverse reaction to any components or excipients of Maraciclatide (99mTc) Injection3. The participant is pregnant or currently breastfeeding, and are unwilling to stop breastfeeding for a minimum of 12 hours after the Maraciclatide (99mTc) Imaging visit4. 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 participation5. Participant with severe renal disease (eGFR < 45 ml/min/1.73m2) or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis6. 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 imaging10. 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, MTP11. The participant has received any radiopharmaceutical within 7 days or 10 half-lives before screening12. The participant has received intramuscular or intravenous steroids < = 4 weeks before screening13. The participant has received intra-articular corticosteroid injections < = 4 weeks before screening14. 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Tim
Hardy
+44 (0)113 3924396
t.hardy@leeds.ac.uk
Dr
Kulveer
Mankia
+44 (0)113 3924396
K.S.Mankia@leeds.ac.uk
The study is sponsored by University of Leeds and funded by National Institute for Health and Care Research; Serac Healthcare Ltd.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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