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NCT04044872 · ClinicalTrials.gov registry record · Early Phase 1
Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity
A Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT04044872: Clinical Trial Early Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT04044872 is a Early Phase 1 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044872, a Early Phase 1 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mitochondrial proteins and alter oxidative phosphorylation and pyruvate metabolism(5). The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical radiation-induced cardiotoxicity.
Primary Outcome
To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction as measured by increase in \[1-13C\]lactate/ \[13C\]bicarbonate ratio and a decrease in \[5-13C\]glutamate formation in patients receiving radiotherapy to the thorax
Interventions
- DIAGNOSTIC_TEST [1-13C]pyruvate along with MRI imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2021-08-30 |
| Phase | Early Phase 1 |
Why NCT04044872 stopped before completion
NCT04044872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which [1-13C]pyruvate along with MRI imaging is the first listed.
NCT04044872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04044872 about?
NCT04044872 is a clinical study titled "Hyperpolarized Carbon 13-Based Metabolic Imaging to Detect Radiation-Induced Cardiotoxicity". Patients enrolled in the study will receive standard of care adjuvant or definitive breast, chest wall or thoracic radiation therapy.Cardiac mitochondrial dysfunction is a hallmark of radiation-induced cardiac injury. Reactive oxygen species (ROS) produced by ionizing radiation cause oxidation of mi...
What is the current status of trial NCT04044872?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2019-12-17. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT04044872?
The interventions under investigation include: [1-13C]pyruvate along with MRI imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04044872?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04044872's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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