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NCT03048097 · ClinicalTrials.gov registry record · Early Phase 1
Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82
A Early Phase 1 study of Sarcoidosis, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03048097: Completed Early Phase 1 study of Sarcoidosis, sponsored by Yale University.
NCT03048097 is a Early Phase 1 study of Sarcoidosis that has completed, run by Yale University. The registered enrollment target is 15 participants, below the 2,169-participant average among 21 other Sarcoidosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03048097, a Early Phase 1 study of Sarcoidosis, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims: Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake. Changes in incubation time can affect imaging target:background ratios and study sensitivity/specificity. For the study-directed exam, all patients will undergo sequential cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging variables will be evaluated as below. Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from initial clinical scan.
Primary Outcome
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Conditions Studied
Interventions
- DRUG Fluorodeoxyglucose
- DRUG Rubidium
- DIAGNOSTIC_TEST FDG-PET/CT with Rb82 Myocardial Perfusion Imaging
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-07-02 |
| Phase | Early Phase 1 |
What the finished NCT03048097 record still lists
NCT03048097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,169-participant average among 21 other Sarcoidosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Sarcoidosis appearing as the primary indexed condition, and to 3 interventions - of which Fluorodeoxyglucose is the first listed.
NCT03048097 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03048097 about?
NCT03048097 is a clinical study titled "Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82". In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims: Aim 1. Effect of FDG incubation ...
What is the current status of trial NCT03048097?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2017-02-01. Estimated completion is 2018-07-02.
What conditions does trial NCT03048097 study?
This clinical trial studies the following conditions: Sarcoidosis.
What interventions are being tested in trial NCT03048097?
The interventions under investigation include: Fluorodeoxyglucose (DRUG), Rubidium (DRUG), FDG-PET/CT with Rb82 Myocardial Perfusion Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03048097?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03048097 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03048097's enrollment target sits among peer trials
15 20th of 21 higher than 2 of 21 other Sarcoidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoidosis 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.
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