Clinical trial · Interventional
Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
NCT03553654CI-TRIAL-00061925completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low dose CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CT monitoring arm
- description
- 18-75 year old patients with newly-diagnosed cancer, scheduled to undergo anthracycline-based chemotherapy.
- interventionNames
- Diagnostic Test: low dose CT
Primary outcomes (1)
- measure
- cardiomyopathy
- timeFrame
- 12 months after completion of chemotherapy
- description
- Cardiomyopathy is defined as a decrease in the left ventricular ejection fraction by echocardiography of greater than 10 percentage points, to a value \< 53% (normal reference value for 2D echocardiography).
Secondary outcomes (3)
- measure
- Change in CT-based left ventricular strain parameters
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent. 2. 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center. 3. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) 4. Women of child-bearing potential must have a negative pregnancy test during the screening period. Exclusion Criteria: 1. Prior chemotherapy with anthracycline; 2. Persistent tachycardia (heart rate\>90); 3. LVEF\<53% or history of cardiomyopathy or decompensated heart failure; 4. Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images; 5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment; 6. Moderate or severe valvular heart disease; 7. Prior allergy or intolerance to iodinated contrast; 8. Renal failure (GFR\<30, creatinine \>1.5); 9. Cancer involvement of the heart.
References
Publications (0)
Data not yet available
No reference posted for this study.