Clinical trial · Interventional
Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients
Doxorubicin-associated Cardiac Tissue Remodeling Followed by CMR of Myocardial Extracellular Volume and Myocyte Size in Breast Cancer Patients
NCT03000036CI-TRIAL-00025243completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva, Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each DOX-cycle.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Doxorubicin Induced Cardiomyopathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Achieva, Philips Medical Systems (3T magnet) | Device | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Gadoterate Meglumine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cardiovascular Magnetic Resonance
- description
- Twenty-seven female patients were imaged in a 3T magnet after consecutively enrolled in the study if they had received a breast cancer diagnosis at the Center for Integral Attention to Women's Health (University of Campinas) and had prescribed endovenous doxorubicin as part of their chemotherapy regimen.
- interventionNames
- Drug: Doxorubicin
- Device: Achieva, Philips Medical Systems (3T magnet)
- Drug: Gadoterate Meglumine
Primary outcomes (2)
- measure
- Quantification of fibrosis index by Cardiac Magnetic Resonance
- timeFrame
- two years
- description
- Estimate the extracellular volume fraction derived from gadolinium-DTPA partition Coefficient of the myocardium
- measure
- Intracellular lifetime of water (τic) by Cardiac Magnetic Resonance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer and had prescribed an anthracycline agent as part of their chemotherapy regimen Exclusion Criteria: * Strict contraindications to MRI * Acute or chronic kidney failure * Previously diagnosed myocardial infarction, heart failure, valvular disease or cardiomyopathy.
References
Publications (26)
- BACKGROUNDKim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003. PMID 11078769
- BACKGROUNDKim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002. doi: 10.1161/01.cir.100.19.1992. PMID 10556226
- BACKGROUNDTandri H, Saranathan M, Rodriguez ER, Martinez C, Bomma C, Nasir K, Rosen B, Lima JA, Calkins H, Bluemke DA. Noninvasive detection of myocardial fibrosis in arrhythmogenic right ventricular cardiomyopathy using delayed-enhancement magnetic resonance imaging. J Am Coll Cardiol. 2005 Jan 4;45(1):98-103. doi: 10.1016/j.jacc.2004.09.053. PMID 15629382
- BACKGROUNDHunold P, Wieneke H, Bruder O, Krueger U, Schlosser T, Erbel R, Barkhausen J. Late enhancement: a new feature in MRI of arrhythmogenic right ventricular cardiomyopathy? J Cardiovasc Magn Reson. 2005;7(4):649-55. doi: 10.1081/jcmr-65608. PMID 16136854
- BACKGROUNDHarris PA, Lorenz CH, Holburn GE, Overholser KA. Regional measurement of the Gd-DTPA tissue partition coefficient in canine myocardium. Magn Reson Med. 1997 Oct;38(4):541-5. doi: 10.1002/mrm.1910380406. PMID 9324319
- BACKGROUNDFlacke SJ, Fischer SE, Lorenz CH. Measurement of the gadopentetate dimeglumine partition coefficient in human myocardium in vivo: normal distribution and elevation in acute and chronic infarction. Radiology. 2001 Mar;218(3):703-10. doi: 10.1148/radiology.218.3.r01fe18703. PMID 11230643
- BACKGROUNDElliott P. Pathogenesis of cardiotoxicity induced by anthracyclines. Semin Oncol. 2006 Jun;33(3 Suppl 8):S2-7. doi: 10.1053/j.seminoncol.2006.04.020.