Clinical trial · Observational
Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
NCT04790266CI-TRIAL-00097460CARDIOTOXcompletedClinicalTrials.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)
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines\* (decline of LVEF ≥10% points with a final LVEF \<53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CMR T2 mapping
- timeFrame
- Time window of 12 months from the end of radiation therapy
- description
- To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines\* (decline of LVEF ≥10% points with a final LVEF \<53%).
Secondary outcomes (10)
- measure
- GLS
- timeFrame
- Time window of 12 months from the end of radiation therapy
- description
- To detect GLS decrease \>15% from baseline, measured on Echo over the time window of 12 months
- measure
- Myocardial edema
- timeFrame
- Time window of 12 months from the end of radiation therapy
- description
- To assess the incidence of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy. To assess the incidence of myocardial oedema on ECHO after radiation therapy and cardiotoxic systemic therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Age ≥ 18 years at visit 1 3. Performance status ECOG 0-1 4. \*Stage I-III histology proven breast cancer 5. Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy 6. Negative pregnancy test (plasma HCG) for all females of childbearing potential (i.e not permanently sterilised- post hysterectomy or tubal ligation status) In the ancillary study patients with stage 0 (DCIS) histology proven breast cancer will also be included. Exclusion Criteria: 1. Known metastatic spread of any cancer 2. Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN 3. Renal function decrease (eGFR \< 30 ml/min) 4. Known coronary artery disease 5. Angina pectoris 6. Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit 7. Patients with baseline LVEF \<53% and GLS \<15% 8. Patients with pacemaker
References
Publications (1)
- DERIVEDBorgonovo G, Vettus E, Greco A, Leo LA, Faletra FF, Klersy C, Curti M, Valli M. Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study. JMIR Res Protoc. 2022 Apr 21;11(4):e31887. doi: 10.2196/31887. PMID 35451989