Functional assessment in bone - osteoclast markers (FAB-O study)
Research type
Research Study
Full title
Imaging avß3 integrin expression in Paget’s disease with 99mTc-maraciclatide single photon emission computed tomography
IRAS ID
136309
Contact name
Gary Cook
Contact email
Sponsor organisation
King's College London
Eudract number
2014-000528-10
Research summary
Paget’s disease is a bone disorder in which the normal repair process is disrupted. Under normal circumstances, osteoclasts breakdown old damaged bone and osteoblasts form new bone. However, in Paget's disease, the osteoclasts are larger than usual and break down bone more rapidly. The osteoblasts respond by depositing new bone at an increased rate, and this eventually leads to an increase in bone size which has an irregular and weakened structure. Paget’s disease is also associated with an increase in blood flow to the areas of abnormal bone by the creation of new blood vessels.
The conventional method to diagnose and monitor patients with Paget’s disease is by performing a whole body bone scan using the radioactive tracer 99mTc-MDP (methylene diphosphonate) which is taken up at sites of new bone formation. However, the disadvantage of this method is that the tracer does not reflect the abnormal osteoclast and blood vessel processes described above. We have a new tracer (99mTc-maraciclatide) that can detect osteoclasts and new blood vessels by binding to the proteins on their cell surface called ‘avß3 integrins’, and we believe that this may be a useful new scanning method to directly detect and monitor these abnormal processes that are the hallmark of Paget’s disease.
The aim of this study is to determine the level and variability of avß3 integrin expression in Paget’s disease by measuring the uptake of 99mTc-maraciclatide in pagetic bone, and comparing the changes in avß3 integrin expression after standard treatment with Zoledronate using 99mTc-maraciclatide and conventional methods in 25 patients with Paget’s disease. By comparing the results of the new tracer with the conventional bone scan and bone turnover markers, we hope to provide data on whether imaging avß3 integrin expression provides a mechanism to detect and monitor Paget’s disease.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0869
Date of REC Opinion
7 Jul 2014
REC opinion
Further Information Favourable Opinion