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NCT06103201 · ClinicalTrials.gov registry record · Phase 1

Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

A Phase 1 study of Traumatic Brain Injury and Subarachnoid Hemorrhage, sponsored by University of Maryland, Baltimore.

Recruiting
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT06103201 is a Phase 1 study of Traumatic Brain Injury and Subarachnoid Hemorrhage that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 15 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06103201, a Phase 1 study of Traumatic Brain Injury and Subarachnoid Hemorrhage, is actively recruiting participants, sponsored by University of Maryland, Baltimore.

RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI. The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study. Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).

Conditions Studied

Traumatic Brain Injury Subarachnoid Hemorrhage

Interventions

  • DRUG Hyperpolarized 13C-Pyruvate

Study Locations (1)

Maryland

  • University of Maryland Baltimore - Baltimore

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-10-26
Est. Completion 2027-11-26
Phase Phase 1

Sponsor

University of Maryland, Baltimore

560 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06103201

The ClinicalTrials.gov registry entry for NCT06103201 describes a study currently listed as recruiting, categorized as 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 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Hyperpolarized 13C-Pyruvate is the first listed.

NCT06103201 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06103201 about?

NCT06103201 is a clinical study titled "Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury". The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived me...

What is the current status of trial NCT06103201?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2023-10-26. Estimated completion is 2027-11-26.

What conditions does trial NCT06103201 study?

This clinical trial studies the following conditions: Traumatic Brain Injury, Subarachnoid Hemorrhage.

What interventions are being tested in trial NCT06103201?

The interventions under investigation include: Hyperpolarized 13C-Pyruvate (DRUG).

Who is sponsoring clinical trial NCT06103201?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06103201 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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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.