Condition category
Cancer
Date applied
14/07/2017
Date assigned
11/08/2017
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
It has been known since the 1970s that chemotherapy with anthracyclines can have adverse side effects on heart function. Between 5 and 30% of all patients treated with anthracyclines develop a decrease in heart function. Nevertheless, anthracyclines play a pivotal role in the treatment of many cancers, such as breast cancers and cancer of the connective tissue (sarcomas). With the fortunate development of increasing numbers of cancer survivors the long-term side effects of chemotherapy become more and more important. The current strategy of assessment of patients for development of heart failure under chemotherapy is mainly based on close observation using ultrasound. There is currently no reliable tool for predicting heart failure under chemotherapy before it actually occurs, or tools for identifying patients at highest risk. MRI is the gold standard for assessment of heart function and has the unique ability to also assess changes in the heart muscle which are known to predict the development of subsequent heart failure. It is thought that chemotherapy with anthracyclines leads to very early changes in the tissue of the heart muscle. These changes may be detectable by MRI and may help to predict the development of heart failure at a much later point in time. Hence, the aim of this study is to assess changes in the heart tissue before and very early (24-48 hours) after the first treatment with anthracyclines using MRI and compare these changes to the development of heart function at the end of chemotherapy treatment (usually after 4-5 months) also assessed by MRI.

Who can participate?
Patients aged at least 18 with sarcoma undergoing chemotherapy with anthracyclines

What does the study involve?
All patients receive three standard MRI scans - one scan before the start of chemotherapy, one 24-48 hours after the first treatment and one 3-4 weeks after the end of chemotherapy. The first and the last MRI scan are part of a normal exam and only the second MRI scan is performed merely due to study participation. Participants also provide blood samples and their heart electrical activity is recorded (electrocardiography [ECG]) at the time of each MRI scan.

What are the benefits and risk of participating?
Benefits include a closer observation of heart function through participation in this study. Extraordinary findings are reported to the referring doctors. One of the three MRI scans is additional and merely performed due to study participation. Since the other two MRI scans are performed anyway, there is no additional burden from a patient's perspective besides the single additional MRI exam.

Where is the study run from?
HELIOS Clinic Berlin-Buch (Germany)

When is the study starting and how long is it expected to run for?
October 2014 to December 2016

Who is funding the study?
1. Charité Universitätsmedizin Berlin (Germany)
2. HELIOS Kliniken (Germany)

Who is the main contact?
Prof. Jeanette Schulz-Menger

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jeanette Schulz-Menger

ORCID ID

Contact details

Charité University Medicine Berlin
Campus Buch
Working group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CARETOX-1

Study information

Scientific title

Assessment of the predictive value of cardiac MRI in anthracycline-induced cardiomyopathy in sarcoma patients

Acronym

CARETOX-1

Study hypothesis

Early changes in cardiac tissue morphology assessable by cardiac MRI can predict the development of subsequent cardiomyopathy in sarcoma patients treated with anthracyclines.

Ethics approval

Ethics board at Charité University Medicine Berlin, Campus Mitte, 23/09/2014, ref: EA1/262/14

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Sarcoma

Intervention

Cardiac tissue morphology is assessed in sarcoma patients treated with anthracycline-based chemotherapy using cardiac MRI. Patients receive at least three cardiac MRI scans: before start of chemotherapy (baseline), 24-48 hours after the first treatment and 3-4 weeks after completion of chemotherapy (usually after 4-5 months).

Blood analysis is carried out at the time of each MRI scan: NTproBnP, high-sensitive Troponin T, hematocrit, glomerular filtration rate. ECG is also carried out at the time of each MRI scan.

Intervention type

Phase

Drug names

Primary outcome measure

Myocardial T1 and T2 times, measured using parametric mapping techniques before start of chemotherapy (baseline), 24-48 hours after the first treatment and 3-4 weeks after completion of chemotherapy (usually after 4-5 months).

Secondary outcome measures

Measured before start of chemotherapy (baseline), 24-48 hours after the first treatment and 3-4 weeks after completion of chemotherapy (usually after 4-5 months):
1. Left and right atrial and ventricular size and function, measured in CINE sequences
2. Detection and size of myocardial fibrosis using late gadolinium enhancement techniques
3. Detection of arrhythmia using ECG
4. Laboratory blood analysis parameters (NTproBNP, hematocrit, high sensitive troponin T, glomerular filtration rate)

Overall trial start date

01/10/2014

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Histologically confirmed sarcoma diagnosis
2. Planned chemotherapy with anthracyclines (cumulative dose >300 mg/m2 doxorubicin-equivalent)
3. Age at least 18 years (no upper limit)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients with first exposition to anthracyclines, 30 patients with re-exposition with anthracyclines

Participant exclusion criteria

1. Any contraindication for contrast-based MRI
2. Chronic renal failure (glomerular filtration rate <30ml/min)
3. Previous participation in this study

Recruitment start date

01/10/2014

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Germany

Trial participating centre

HELIOS Clinic Berlin-Buch
13125

Sponsor information

Organisation

Charité University Medicine Berlin

Sponsor details

Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Sponsor type

University/education

Website

http://www.cmr-berlin.org

Funders

Funder type

University/education

Funder name

Charité Universitätsmedizin Berlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Funder name

HELIOS Kliniken

Alternative name(s)

HELIOS Kliniken GmbH

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Results and Publications

Publication and dissemination plan

Results of this study shall be published in two high-ranking peer-reviewed journal publication. One publication for each study group (group 1: first exposure to anthracyclines, group 2: re-exposure to anthracyclines - for details see above).

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection laws in Germany. However, upon request methodology and dataset structure can be shared.

Intention to publish date

28/02/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes