Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver Transplantation
Condition: Graft Rejection; Heart Transplantation; Liver Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The a series of clinical studies of [18F]FSPG PET/CT showed that [18F]FSPG is safe and
      promising PET tracer for detecting inflammation with favorable biodistribution and
      pharmacokinetics in patients. By using [18F]FSPG, which targets system xCˉ, a key player in
      the active phase of inflammation, the goal of this phase 2 study is to evaluate diagnostic
      validity of [18F]FSPG PET/CT to detect allograft rejection after heart and liver allograft,
      where conventional imaging has limitations. Diagnostic efficacy of [18F]FSPG PET/CT will be
      determined in comparison with histologic evaluation of allograft biopsy. Other critical
      questions including whether quantitative measures of [18F]FSPG uptake is associated with the
      severity of rejection, inter-reader variability of [18F]FSPG PET/CT, and safety assessment
      will be also evaluated.
    

Detailed description: 
      This open label, non-randomized, single center, single-dose exploratory study is designed to
      obtain imaging assessments using PET/CT with [18F]FSPG in patients with heart transplantation
      (HT, n = 10) and liver transplantation (LT, n = 10). Subjects who underwent or scheduled to
      undergo biopsy for histologic diagnosis of acute rejection will be enrolled.

      The study comprises 3 periods: screening, treatment, and follow-up. The screening period
      starts with the subject's signature on the informed consent form and ends with assignment to
      treatment that is inclusion of the subject for treatment. The treatment period starts with
      baseline measurements, and ends with the last measurement/procedure on the day following
      injection of 200 MBq of [18F]FSPG. The follow-up period contains the end-of-study interview.
      Key measurement is the PET/CT image acquisition about one hour after the single injection of
      [18F]FSPG. For evaluation of safety, adverse events (AE) will be monitored and recorded
      during the study period.

      This study will be monitored regularly by a clinical research associate from the sponsor or a
      designated contract research organization. Data quality and study integrity will be assessed.
      The investigator will document the items that are required to evaluate the study in the
      subject files. Data required according to this protocol are to be recorded on the case report
      forms provided by the sponsor as soon as possible.
    

Intervention name(s): [18F]FSPG
Intervention type(s): Drug
Intervention description(s): A radioactive dose of 200 MBq of the study drug with a total quantity of ≤ 100 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 60-75 min after the administration of [18F]FSPG.
Other intervention name(s): FSPG
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients suspected of having acute allograft rejection after heart transplantation (HT, n = 10) or liver transplantation (LT, n = 10)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Graft Rejection; Heart Transplantation; Liver Transplantation; Positron-Emission Tomography; Diagnostic Imaging