Status:
COMPLETED
Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver Transplantation
Lead Sponsor:
Asan Medical Center
Conditions:
Graft Rejection
Heart Transplantation
Eligibility:
All Genders
19-79 years
Phase:
PHASE2
Brief 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 patien...
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...
Eligibility Criteria
Inclusion
- Subject is aged between 19 and 79 years and male or female of any race/ethnicity.
- Subject received heart transplantation or liver transplantation at least 30 days prior to screening
- Subject underwent or is scheduled to undergo biopsy for histologic diagnosis of acute rejection within 7 days prior to or after the planned \[18F\]FSPG PET/CT administration.
Exclusion
- Subject or subject's legally acceptable representative does not provide written informed consent.
- Dose escalation of the current immunosuppressant drugs or starting a new immunosuppressant is scheduled from the study enrollment to the scheduled day of biopsy, or 24 hours after \[18F\]FSPG administration
- Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]FSPG has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
- Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) in the judgment of the investigator.
- Subject is a relative of the investigator, student of the investigator or otherwise dependent.
- Subject has received any investigational drugs or devices within four weeks prior to the study enrollment or within 24 hours after administration of \[18F\]FSPG.
- Subject has been previously included in this study.
- Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04488094
Start Date
November 18 2020
End Date
March 31 2023
Last Update
July 20 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea, 05505