Serial cardiac magnetic resonance imaging (CMR) with contrast agents and biomarker analysis for the detection of cardiotoxicity under anthracycline-containing cancer therapy - A monocentric, low interventional Phase IV pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

4 Mar 2026 → ongoing

Decision date (initial)

2025-08-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

RBMF; internal funds of the trial site (see study protocol section 24)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The aim of the study is to analyze whether CMR is potentially suitable for the early detection of myocardial damage in oncology patients receiving anthracycline treatment.

Secondary objectives 1

1. see study protocol section 3 `study objectives´

Conditions and MedDRA coding

Anthracycline-based antineoplastic therapy (standard of care/routine treatment)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Female and male persons > 18 years of age
2. Patients to be treated with at least 4 cycles of anthracycline-based antineoplastic therapy
3. Written informed consent form

Exclusion criteria 17

1. Lack of capacity to consent
2. Simultaneous participation in another clinical trial or previous participation in another clinical trial in the last 3 months prior to study inclusion
3. Kidney damage with a GFR <30 ml/min/1.73 m²
4. Patients in the perioperative phase of a liver transplantion
5. Metal implants, e.g. cardiac pacemakers, which are a contraindication for an MRI examination
6. Vulnerable population (persons who are unable to protect and represent their own interests with regard to illness, disability, mental illness, intellectual development, cognitive impairment and prisoners) are not included in this study
7. Pregnant or breastfeeding women
8. Known hypersensitivity to contrast agents containing gadolinium
9. Patient information not possible (e.g. language barrier)
10. Patients who have already received anthracycline therapy
11. Persons who have received therapy with the following myocardial-toxic drugs within the last 6 months prior to study inclusion - High-dose cyclophosphamide (>1000mg/m2, >10mg/kg) - HER2 inhibitors - VEGF inhibitors - BCR-ABL inhibitors - BRAF inhibitors - MEK inhibitors - Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors)
12. Therapy with fewer than 4 planned cycles of antracycline-containing therapy (e.g. induction therapy for AML)
13. Therapies in which antracyclines are not applied in every cycle
14. Planned invasive cardiac procedure during the study period
15. Known cardiac involvement of an existing disease, e.g. amyloidosis
16. Treatment with liposomal forms of therapy, such as liposomal daunorubicin/cytarabine (CPX-351) or liposomal doxorubicin
17. Radiotherapy with a thoracic radiation field that was performed prior to the planned anthracycline-containing therapy (radiotherapy for non-thoracic lesions prior to study inclusion is not considered an exclusion criterion)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in the T2-weighted relaxation time in myocardial mapping

Secondary endpoints 4

1. Further abnormal CMR findings (morphology, function, perfusion, LGE and residual parametric mapping (T1-weighted relaxation time, extracellular volume)) during and after completion of anthracycline-based chemotherapy, analyzed by two different investigators
2. Troponin T and NT-proBNP before, during and after completion of anthracycline-based chemotherapy in correlation with CMR results
3. Echocardiographically determined Global Longitudinal Strain before, during and after completion of anthracycline-based chemotherapy in correlation to CMR results
4. Validation and/or identification of new biomarkers (e.g. genetic markers) using the biomaterials

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Sponsor organisation

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Address

Auerbachstrasse 112, Bad Cannstatt Bad Cannstatt

City

Stuttgart

Postcode

70376

Country

Germany

Scientific contact point

Organisation

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Contact name

Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology (IKP)

Public contact point

Organisation

Robert Bosch Gesellschaft fuer medizinische Forschung mbH

Contact name

Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology (IKP)

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications