Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver Transplantation

Summary

Participation Requirements

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 hi...

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.

Tracking Information