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NCT04234880 · ClinicalTrials.gov registry record

High-resolution Phosphocreatine and Creatine Mapping of Human Muscle and Brain

A clinical trial of Healthy, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

Recruiting
Registry status
50
Enrollment target
1
Study location

NCT04234880 is a study of Healthy that is actively recruiting participants, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 50 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04234880, a study of Healthy, is actively recruiting participants, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

RECRUITING
Registry status
50 participants
Enrollment target
1
Study location

Study Summary

In this study, we aim to develop and validate a noninvasive approach for quantifying and imaging energy metabolism, without contrast agents, on widely available clinical MRI scanners. Briefly, this technique allows specific and selective imaging of the energy metabolite phosphocreatine (PCr), in vivo and non-invasively. PCr is one of the predominant high-energy phosphates present in brain and muscle and one that is altered by common diseases. Although energy metabolism and PCr play a vital role in cellular homeostasis, there currently are no routine diagnostic tests to noninvasively quantify or map the distribution of PCr with clinically acceptable spatial resolution or/and scan time. Here, we demonstrate that the exchangeable guanidinium protons of millimolar concentration PCr can be exploited to detect it via the water signal in MRI with greatly enhanced sensitivity (molar signal) using chemical exchange saturation transfer (CEST) MRI, and its concentration can be quantified using an artificial neural network (ANN). This new technique, dubbed ANNCEST, allowed us to obtain a high-resolution PCr map on human skeletal muscle within 1.5 min, on a 3T clinical MRI scanner equipped with just the standard MRI setup. To put this in a larger perspective, energy metabolism is critical for cell viability and is altered by many common acquired and inherited diseases. ANNCEST is arguably the first to use widely available MRI scanners to noninvasively image tissue energy metabolism of PCr, and thus would have appeal to a broad readership of scientists and clinicians interested in neurology, muscular dystrophies and myopathies as well as cardiology, to name a few.

Conditions Studied

Study Locations (1)

Maryland

  • F. M. Kirby Center and Johns Hopkins University Medical School - Baltimore

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-01-01
Est. Completion 2030-12-30

What the Registry Record Tells You About NCT04234880

The ClinicalTrials.gov registry entry for NCT04234880 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 0 interventions.

NCT04234880 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04234880 about?

NCT04234880 is a clinical study titled "High-resolution Phosphocreatine and Creatine Mapping of Human Muscle and Brain". In this study, we aim to develop and validate a noninvasive approach for quantifying and imaging energy metabolism, without contrast agents, on widely available clinical MRI scanners. Briefly, this technique allows specific and selective imaging of the energy metabolite phosphocreatine (PCr), in viv...

What is the current status of trial NCT04234880?

This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2018-01-01. Estimated completion is 2030-12-30.

What conditions does trial NCT04234880 study?

This clinical trial studies the following conditions: Healthy.

Who is sponsoring clinical trial NCT04234880?

This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04234880 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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