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Magnetic Resonance Imaging:A Window to Anthracycline Toxicity
This study has been completed.
Sponsor:
Connecticut Children's Medical Center
Information provided by (Responsible Party):
Olga Salazar, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT03211520
First received: February 13, 2017
Last updated: July 5, 2017
Last verified: June 2017
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Purpose
The study is being conducted to see which cardiac tests that monitor how the heart functions during and after treatment with anthracyclines are most effective. This study will assess a new way to check the heart function of children during and after cancer treatment. Currently, doctors use echocardiograms (heart ultrasound) to see how the heart is working. Echocardiograms are currently being done as part of standard of care prior to giving anthracycline chemotherapy doses and if any cardiac problems are suspected. The new method involves Cardiac Magnetic Resonance Imagining (CMRI) and a blood tests for certain biomarkers for heart health: High sensitivity troponin, Caspase, C-reactive Protein (CRP), ventricular derived B-type natriuretic peptide (BNP), Matrix Metalloproteinases (MMPs), Tissue inhibitors of metalloproteinases (TIMPs), C terminal propeptide of type I procollagen (PICP), C terminal telopeptide of collagen type I (CITP), Troponin I, and Bone Alkaline Phosphatase. The purpose of this study is to find out if CMRI and blood tests help us to find heart problems earlier, before they are detected by echocardiograms.
| Condition |
|---|
| Cardiac Complications |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Magnetic Resonance Imaging:A Window to Anthracycline Toxicity |
Resource links provided by NLM:
Further study details as provided by Olga Salazar, Connecticut Children's Medical Center:
Primary Outcome Measures:
- Myocardial edema [ Time Frame: Time points will be measured over a 1 year time frame ]Myocardial edema in the acute phase measured by a composite of multiple measures that include T1 and T2 mapping, signal enhancement in T2 weighted images.
- Regional wall motion abnormalities [ Time Frame: Time points will be measured over a 1 year time frame ]Decrease in myocardial strain and strain rate compared to baseline calculations
- Biomarkers of adverse cardiac remodeling [ Time Frame: Time points will be measured over a 1 year time frame ]Elevation of serologic biomarkers CRP, Troponin, Caspases, BNP, and extracellular matrix remodeling (PCIP, CITP, PICP/CITP ratio, MMPs and MMPs/TIMP ratio
Biospecimen Retention: Samples Without DNA
Pending
| Enrollment: | 13 |
| Study Start Date: | February 2013 |
| Study Completion Date: | June 24, 2016 |
| Primary Completion Date: | June 24, 2016 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Age group is greater than or equal to 9 years of age, have a cancer diagnosis that will be treated with anthracyclines
Criteria
Inclusion Criteria:
- - Age (≥9years old)
- Newly diagnosed with a malignancy that is anticipated to receive high dose anthracyclines as part of their chemotherapy (such as but not limited to solid tumors, high risk ALL, AML, and lymphomas)
- Parental/caregiver consent and subject assent to enrollment
Exclusion Criteria:
- - Contraindications to CMRI.*
- Patients requiring sedation for the CMRI procedure
- Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
- Subject is too large to be safely accommodated by MRI
- Serum Creatinine higher than the quidelines for adequate renal function
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211520
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211520
Locations
| United States, Connecticut | |
| Connecticut Childrens Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
| Principal Investigator: | Olga Salazar, MD | Connecticut Childrens Medical Center |
More Information
| Responsible Party: | Olga Salazar, Director of non-invasive Cardiac Imaging, Assoc. Professor of Pediatrics, Connecticut Children's Medical Center |
| ClinicalTrials.gov Identifier: | NCT03211520 History of Changes |
| Other Study ID Numbers: |
10-066 |
| Study First Received: | February 13, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Pending PI review |
Keywords provided by Olga Salazar, Connecticut Children's Medical Center:
|
Cancer treatment Anthracyclines Cardiac MRI |
ClinicalTrials.gov processed this record on July 11, 2017