Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04488094
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT04488094
Study Brief:
Protocol Section:
NCT04488094