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NCT01066637 · ClinicalTrials.gov registry record · Early Phase 1
iNOS With Positron Emission Tomography (PET) in Cellular Inflammation.
A Early Phase 1 study of Patients With Post Orthotopic Heart Transplantation Status, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01066637: Completed Early Phase 1 study of Patients With Post Orthotopic Heart Transplantation Status, sponsored by Washington University School of Medicine.
NCT01066637 is a Early Phase 1 study of Patients With Post Orthotopic Heart Transplantation Status that has completed, run by Washington University School of Medicine. The registered enrollment target is 26 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01066637, a Early Phase 1 study of Patients With Post Orthotopic Heart Transplantation Status, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG [18F](+/-)NOS
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-06 |
| Phase | Early Phase 1 |
What the finished NCT01066637 record still lists
NCT01066637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Patients With Post Orthotopic Heart Transplantation Status appearing as the primary indexed condition, and to 1 intervention - of which [18F](+/-)NOS is the first listed.
NCT01066637 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT01066637 about?
NCT01066637 is a clinical study titled "iNOS With Positron Emission Tomography (PET) in Cellular Inflammation.". 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 rou...
What is the current status of trial NCT01066637?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2009-09. Estimated completion is 2012-06.
What conditions does trial NCT01066637 study?
This clinical trial studies the following conditions: Patients With Post Orthotopic Heart Transplantation Status.
What interventions are being tested in trial NCT01066637?
The interventions under investigation include: [18F](+/-)NOS (DRUG).
Who is sponsoring clinical trial NCT01066637?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01066637 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01066637's enrollment target sits among peer trials
26 977th of 2000 higher than 1,002 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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