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

NCT04488094 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Graft Rejection
  • Heart Transplantation
  • Liver Transplantation

Interventions

DRUG

[18F]FSPG

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Dae Hyuk Moon, MD · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488094 on ClinicalTrials.gov