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Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate

Study acronym: HPTBI
StatusEnrolling by Invitation
PhaseEarly Phase 1
Started2018-06-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2026 → Dec 30, 2026
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-08-31
Study Status, Oversight v13
Primary completion pushed: 2026-06-30 → 2026-12-30
Completion pushed: 2026-06-30 → 2026-12-30
2025-08-19
Study Status v12
Primary completion date2025-06-30→2026-06-30
Completion date2025-06-30→2026-06-30
2024-09-19
3 amendments v9-v11
3 re-verifications since 2022-09-28, no change to tracked fields
2021-09-27
Active, Not Recruiting→Enrolling by Invitation Study Status, Study Design, Eligibility, IPDSharing v8
Trial statusActive, Not Recruiting→Enrolling by Invitation
Enrollment target16→60
Eligibility criteriarevised
Inclusion Criteria: TBI Patients Injury occurred within 1030 days Documented and verified TBI by Glascow coma scal 10-15 [...]
2021-05-19
Study Status v7
Re-verified, no change to tracked fields
Show 6 earlier versions
2020-05-20
Enrolling by Invitation→Active, Not Recruiting Study Status v6
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2020-12-31→2025-06-30
Completion date2020-12-31→2025-06-30
2019-09-11
Study Status v5
Re-verified, no change to tracked fields
2019-03-28
Study Status v4
Primary completion date2019-10-31→2020-12-31
Completion date2020-10-31→2020-12-31
2018-07-31
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2019-05-01→confirmed 2018-06-01
Study sites0→1
2018-06-06
Study Status v2
Start date2018-05-01→2019-05-01
2018-04-23
Study Status, Study Description v1
Study description+11 characters
Aim 1: WeInvestigators will quantify changes in [1-13C]lactate and H13CO3- labelin [...]
2018-04-11
Original filing
This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.
Trial Details
NCT Number NCT03502967
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Traumatic Brain Injury
Enrollment 60 participants
Start Date 2018-06-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03