99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Status:
Terminated
Trial end date:
2018-11-12
Target enrollment:
Participant gender:
Summary
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the
investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA)
lesions.
Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5
patients were enrolled into a "proof of concept" phase, to assess the imaging potential of
99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and
medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide
whether to terminate the study or whether to continue and enroll the next 15 planned
patients.