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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 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.

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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.

Conditions Studied

Sarcoidosis

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

FieldValue
Enrollment Target 15 participants
Start Date 2017-02-01
Est. Completion 2018-07-02
Phase Early Phase 1

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT03048097

The ClinicalTrials.gov registry entry for NCT03048097 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,169-participant average among 21 other Sarcoidosis trials with a reported enrollment target (99% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.