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Cardiac ComplicationsNCT03211520

Magnetic Resonance Imaging:A Window to Anthracycline Toxicity

An observational study of Cardiac Complications, run by Connecticut Children's Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 18 years
Conditions the study is for
Cardiac Complications
How many people
13 participants
Where
1 siteUnited States
Study dates
Feb 2013to 24 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Age group is greater than or equal to 9 years of age, have a cancer diagnosis that will be treated with anthracyclines

Who may be able to join

  • - 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

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Olga H Toro-Salazar

    Hartford, Connecticut, 06106

Other trials in United States

About this study

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.

Read the detailed description

This is a pilot study with a descriptive study design.

Anthracycline induced late onset cardiotoxicity, defined in terms of abnormal findings on echocardiography, has been reported to occur in 57% of childhood cancer survivors. Serial monitoring of cardiac function by means of echocardiography detects cardiac toxicity only when many of the cardiomyocytes have already been damaged. Given the lack of evidence to support the reliability of serum markers of cardiotoxicity, many recommend modifying the dose of anthracyclines only when there is objective evidence of myocardial dysfunction by echocardiograph. This approach could be responsible for the increasing frequency of dilated cardiomyopathy occurring 10-15 years after treatment. Non invasive imaging methods are thus critically needed to more precisely detect cardiotoxic changes in children receiving anthracyclines. CMRI has become the gold standard for the assessment and quantification of ventricular volumes, myocardial mass and global and regional wall function. CMRI also allows morphologic analysis of the myocardium as well as detection and characterization of pathological myocardium. In this study, the investigator therefore proposes to use serial MRI parameters in conjunction with a battery of serologic markers, obtained at intervals determined by cumulative anthracycline dose, to monitor changes in systolic function during chemotherapy and one year after the end of chemotherapy. The investigator will use a combination of a serum cardiac biomarker of inflammation (CRP), myocyte injury (Troponin, Caspases), heart failure (BNP), and extracellular matrix remodeling (PICP, CITP, Bone Alkaline Phosphatase, MMPs, TIMPs). The investigator will then correlate these findings with CMRI parameters of myocyte dysfunction. Results will be compared with standard echocardiography. The investigator predict that CMRI is a better indicator of early anthracycline cardiotoxicity in children with solid tumors and hematologic malignancies.

Patients who are of age 9 years of age or older, 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) will be invited to participate in the study.

Specific Aim 1: To use CMRI to detect occult asymptomatic cardiotoxicity over time and in relation to cumulative dose among pediatric cancer patients treated with anthracyclines.

Specific Aim 2: To quantitate serologic biomarker profile for several functional pathways including the inflammatory cascade, MMP/TIMP remodeling pathways, signaling, cell viability and growth domains over time and in relation to cumulative dose among pediatric cancer patients treated with anthracyclines.

Specific Aim 3: To compare changes over time detected by CMRI and serologic markers of cardiac toxicity to echocardiographic indices of systolic and diastolic function and determine their ability alone or in combination to predict freedom from left ventricular dysfunction defined as change in ejection fraction at one year post chemotherapy.

These aims will test the hypothesis that CMR imaging and serologic biomarkers of inflammation, apoptosis and progressive extracellular matrix remodeling will precede echocardiographic indices of systolic and diastolic function among children receiving high dose anthracyclines as part of their chemotherapy protocol.

Study Outcome Measures

Myocardial edema in the acute phase measured by the following parameters:

  • Increased myocardial mass.
  • Focal areas of high signal intensity T2 weighted spin echo imaging and myocardial delayed enhancement. Significant enhancement will be defined as signal intensity increases of greater than two standard deviations above the mean value of remote normal myocardium.
  • Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique
  • Changes in myocardial T1 relaxation time in the myocardium pre and post-contrast compared to baseline as measured by T1 mapping technique (Modified Look-Locker inversion recovery (MOLLI). Myocardial T1 (msc).
  • Decrease in myocardial strain and strain rate compared to baseline calculations: Mid wall left ventricular circumferential strain (ECC), Maximum longitudinal left ventricular strain (ELL).
  • Decrease in myocardial T2* indicative of presence of Iron in the myocardium (reflecting anthracycline-Fe complexes)(ms).
  • The following markers were measured: Matrix/Fibrosis pathway:

Plasma levels of MMPs (all soluble MMP types) and TIMPs (all 4 TIMPs); Inflammatory domain: cytokines (TNFα, interleukins, interferon gamma (IFNG), TGF β2, TGF βII)),cytokine receptors (sTNF RI, sTNF RII, sSt2, sgp130, siL1-RII/sCD121b, siL-2Rα/CD25, siL-4R, siL-6R, Endoglin); Signaling pathway: growth factors (GDP-15, GCSF, VEGF, sVEGFR2 TGFβ1, IGF-1;). Changes in regional myocardial function and elevation of serologic markers may predict freedom from left ventricular dysfunction defined as ejection fraction ≥55% at 1 year.

The following tests and procedures will be done for this study:

  1. CMRI tests
  2. Blood tests
  3. Echocardiograms

These tests noted above will be done:

  1. Prior to or at before the cum dose of anthracyclines = 60 mg/m2
  2. Cumulative anthracycline doses:
  • 125-175 mg/m2
  • 200-250 mg/m2
  • 275-325 mg/m2
  • After maximal anthracycline treatment
  • One year after completion of maximal anthracycline therapy

The blood tests being done are:

Matrix/Fibrosis pathway:Plasma levels of MMPs (all soluble MMP types) and TIMPs, (all 4 TIMPs); Inflammatory domain: cytokines (TNFα, interleukins, interferon gamma (IFNG), TGF β2, TGF βII)), Cytokine receptors (sTNF RI, sTNF RII, sSt2, sgp130, siL1- RII/sCD121b, siL-2Rα/CD25, siL-4R, siL-6R, Endoglin); Signaling pathway: growth factors (GDP-15, GCSF, VEGF, sVEGFR2 TGFβ1, IGF-1;

Keywords
Cancer treatment, Anthracyclines, Cardiac MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time points will be measured over a 1 year time frame

  2. Regional wall motion abnormalities

    Decrease in myocardial strain and strain rate compared to baseline calculations

    Measured: Time points will be measured over a 1 year time frame

  3. 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

    Measured: Time points will be measured over a 1 year time frame

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study startFeb 2013
  3. Primary completion24 Jun 2016
  4. Study completion24 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03211520
Sponsor's protocol ID
10-066
Status last verified
May 2025
First submitted
13 Feb 2017
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29900007

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Complications, run by Connecticut Children's Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial edema (time frame: Time points will be measured over a 1 year time frame). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03211520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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