CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 26 enrolled
Drug / intervention
[18F](+/-)NOSdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01066637
NCT01066637Early Ph 1Completed

Imaging iNOS Activity Using [18F] (+/-) NOS With Positron Emission Tomography (PET) in Cellular Inflammation.

Washington University School of Medicine·interventional·Posted Feb 10, 2010·Updated Aug 7, 2020

In Brief

A Early Phase 1 clinical trial evaluating [18F](+/-)NOS for Patients With Post Orthotopic Heart Transplantation Status. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The primary purpose of this study is to measure the level of an enzyme in a patient's heart called inducible nitric oxide synthase(iNOS) using Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-NOS. These PET results will be compared to tissue results obtained during routine endomyocardial heart biopsy. The enzyme iNOS produces nitric oxide in inflammatory diseases such as acute heart transplant rejection, diabetes, Alzheimer's and cancer. Thus, PET with the radioactive tracer 18F-NOS may be a useful tool for detecting the early stages of these diseases. The safety of 18F-NOS during the study will also be assessed. All PET imaging will be performed with a CTI/Siemens Biograph 40 PET/CT scanner. Protocol was revised to add new imaging modality, Biograph mMR PET-MR scanner in order to investigate new hardware and software in order to optimize scanning procedures in order to refine image quality so that we can apply the findings to future standard clinical scans and research imaging studies. Ten additional status-post OHT patients who are scheduled for standard of care endomyocardial biopsy for allograft rejection surveillance will undergo PET/MR imaging with \[18F\](+/-)NOS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2010
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.4 years ago

Interventions

[18F](+/-)NOSdrug

Injection of radiotracer \[18F\](+/-)NOS for PET imaging and kinetic data analysis