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NCT03685175 · ClinicalTrials.gov registry record · Early Phase 1
Using Hyperpolarized [1-13C]Pyruvate to Detect Cardiotoxicity
A Early Phase 1 study of Breast Neoplasms, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT03685175: Completed Early Phase 1 study of Breast Neoplasms, sponsored by University of Texas Southwestern Medical Center.
NCT03685175 is a Early Phase 1 study of Breast Neoplasms that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 79 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03685175, a Early Phase 1 study of Breast Neoplasms, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
Study Summary
The anthracycline doxorubicin, first introduced in the 1960's, continues to be an effectively utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a potential risk for late effects in cancer survivors. Doxorubicin has systemic toxicity that may contribute to cardiac metabolic stress, but the main cardiotoxic mechanism involves cardiac mitochondria. The primary goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical doxorubicin induced cardiotoxicity. The problem of cardiovascular complications following chemotherapy for breast cancer goes far beyond anthracyclines alone. In addition, other agents such as trastuzumab, and pertuzumab and emerging novel therapies may also promote cardiovascular injury. The secondary objective is to test the hypothesis that cardiotoxicity due to other medical anticancer therapies and radiation therapy involving the heart field is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase.
Primary Outcome
Detect the correlation between cardiac carbon-13 pyruvate metabolism and cardiac mechanical function at baseline and after exposure to cardiotoxic therapy
Conditions Studied
Interventions
- DRUG Formal study using hyperpolarized 13C-pyruvate injection
- DRUG Feasible study using hyperpolarized 13C-pyruvate injection
Study Locations (1)
Texas
- UT Southwestern - Advanced Imaging Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2025-02-28 |
| Phase | Early Phase 1 |
What the finished NCT03685175 record still lists
NCT03685175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Formal study using hyperpolarized 13C-pyruvate injection is the first listed.
NCT03685175 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03685175 about?
NCT03685175 is a clinical study titled "Using Hyperpolarized [1-13C]Pyruvate to Detect Cardiotoxicity". The anthracycline doxorubicin, first introduced in the 1960's, continues to be an effectively utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a potential risk for late e...
What is the current status of trial NCT03685175?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 79 participants. The study started on 2018-07-03. Estimated completion is 2025-02-28.
What conditions does trial NCT03685175 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT03685175?
The interventions under investigation include: Formal study using hyperpolarized 13C-pyruvate injection (DRUG), Feasible study using hyperpolarized 13C-pyruvate injection (DRUG).
Who is sponsoring clinical trial NCT03685175?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03685175 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
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 NCT03685175's enrollment target sits among peer trials
79 63rd of 97 higher than 32 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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