The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.

• Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.

Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.

Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.

22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.

The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.

The trial failed primary outcome, and this secondary outcome was not analyzed

An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.

The trial failed primary outcome, and this secondary outcome was not analyzed.

The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.

The trial failed primary outcome, and this secondary outcome was not analyzed.

The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.

The trial failed primary outcome, and this secondary outcome was not analyzed.