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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

To assess the differences between the three patient groups

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
University of Maryland, Baltimore

560 total trials

What NCT06103201 shows while recruiting

NCT06103201 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 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Similar trials for Traumatic Brain Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06103201's enrollment target sits among peer trials

15 156th of 171 higher than 12 of 171 other Traumatic Brain Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Traumatic Brain Injury 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06103201, the US trial registry maintained by the National Library of Medicine. NCT06103201 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.