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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06103201
Other study ID # HP-00104422
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 26, 2023
Est. completion date November 26, 2026

Study information

Verified date April 2024
Source University of Maryland, Baltimore
Contact Rosy Linda Njonkou Tchoquessi
Phone 410-706-0943
Email rnjonkou@som.umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date November 26, 2026
Est. primary completion date November 26, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - History of acute head injury with or suspected non-penetrating acute TBI - Suitable to undergo contrast-enhanced MRI - Negative serum pregnancy test Exclusion Criteria: - Inability to undergo MRI scan - Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency - Positive pregnancy test

Study Design


Intervention

Drug:
Hyperpolarized 13C-Pyruvate
Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, traumatic brain injury. Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, which refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997].

Locations

Country Name City State
United States University of Maryland Baltimore Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio) To assess the differences between the three patient groups within two years post enrollment
Secondary Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation. within two years post enrollment
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