Clinical trial · Observational
Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy
Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy: A Cardiac Magnetic Resonance and Biomarker Imaging and Serological Biomarker Study
NCT01671696CI-TRIAL-00100046completedClinicalTrials.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)
The main hypothesis being tested is that magnetic resonance imaging and serologic biomarkers of apoptosis and extracellular matrix remodeling will precede echocardiographic indices of systolic and diastolic function among childhood cancer survivors treated with anthracyclines thus allowing evaluation of new therapies to prevent and manage heart failure in these patients.
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 |
|---|---|---|---|
| Cardiovascular Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity
- timeFrame
- 2 year
- description
- Changes in T1 mapping-derived relaxation time and left ventricular myocardial peak circumferential and longitudinal strain magnitude and segmental circumferential strain magnitude are present in asymptomatic post-chemotherapy pediatric patients who have normal standard CMRI parameters. Circumferential strain analysis and measurement of the T1 myocardial relaxation time by CMRI may accurately identify occult cardiovascular dysfunction in patients exposed to high dose anthracyclines.
Secondary outcomes (1)
- measure
- To quantitate serological markers of diffuse myocardial fibrosis and apoptosis
- timeFrame
- 1 year
- description
- Testing changes in extracellular matrix remodeling and increases in tissue apoptosis occur in asymptomatic post chemotherapy patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 35 Years
Show eligibility criteria text
5.1 A. Subject Inclusion Criteria * Childhood cancer survivors from the late effect clinic who had received ≥240 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 2 years. * Age \> 9 years of age\* * Parental/caregiver consent and subject assent to enrollment \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation B. Subject Inclusion Criteria * Enrolled in part A of the study, which took place from October 2011 to July 2013. * Parental/caregiver consent and subject assent to enrollment C. Subject Inclusion Criteria * Childhood cancer survivors from the late effect clinic who had received \< 300 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 1 year * Age ≥ 9 years of age\* * Parental/caregiver consent and subject assent to enrollment * \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation 5.2 A. Subject Exclusion Criteria * Contraindications to CMRI.\* * Pregnancy\*\* \* Contraindications to CMRI (i.e., magnetically activated implants/devices; cardiac pacemaker or wires; after the patients are scheduled for CMRI, they will be sent our standard pre-MRI paperwork/questionnaire, to determine eligibility to have an MRI) \*\*If a female patient of child bearing age is not sure if they are pregnant or not, as part of the standard CMRI with contrast procedures, a urine pregnancy test will be done. If the result is positive the subject will not be allowed to continue in the study. CMRI with gadolinium may affect a fetus, and also the CMRI results are an integral part of this research study. * Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye. B. Subject Exclusion Criteria * Not enrolled in part A of the study * Contraindications to CMRI\* * Pregnancy \*\* * Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye * C. Subject Exclusion Criteria * Total Cumulative dose anthracyclines ≥300 mg/m2 * Contraindications to CMRI\* * Pregnancy \*\* * Orbital X-Ray confirmed to have metal in the eye or patient confirmed to have metal in the eye Exclusion Criteria: * Contraindications to CMRI * Relapse of their cancer * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.