Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Early Phase 1

Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82

NCT03048097 · View on ClinicalTrials.gov ↗

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

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

1,283 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03048097

The ClinicalTrials.gov registry entry for NCT03048097 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03048097 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03048097?

This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial