Magnetic Resonance Imaging:A Window to Anthracycline Toxicity

NCT03211520 | Completed

• 1 other identifier: 10-066
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Complications

Keywords

Cancer treatment; Anthracyclines; Cardiac MRI

Outcome Measures

Primary Outcomes (3)

• Myocardial edema

  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.

  Time points will be measured over a 1 year time frame

• Regional wall motion abnormalities

  Decrease in myocardial strain and strain rate compared to baseline calculations

  Time points will be measured over a 1 year time frame

• Biomarkers of adverse cardiac remodeling

  Elevation of serologic biomarkers CRP, Troponin, Caspases, BNP, and extracellular matrix remodeling (PCIP, CITP, PICP/CITP ratio, MMPs and MMPs/TIMP ratio

  Time points will be measured over a 1 year time frame

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• \- 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 Acute Lymphocytic Leukemia, Acute myelogenous Leukemia and lymphomas)
• Parental/caregiver consent and subject assent to enrollment

You may not qualify if:

• \- 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 guidelines for adequate renal function

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Olga H Toro-Salazar

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Toro-Salazar OH, Lee JH, Zellars KN, Perreault PE, Mason KC, Wang Z, Hor KN, Gillan E, Zeiss CJ, Gatti DM, Davey BT, Kutty S, Liang BT, Spinale FG. Use of integrated imaging and serum biomarker profiles to identify subclinical dysfunction in pediatric cancer patients treated with anthracyclines. Cardiooncology. 2018;4:4. doi: 10.1186/s40959-018-0030-5. Epub 2018 May 1.

  PMID: 29900007 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pending

Study Officials

• Tiffany Berthod (Ruiz), MSN, RN, CPN, CCRC

  Connecticut Childrens Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardio-oncology nurse program manager

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: July 7, 2017
• Study Start: February 1, 2013
• Primary Completion: June 24, 2016
• Study Completion: June 24, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)