MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC)
Given the lack of data on the incidence of subclinical cardiotoxicity after treatment with
TAC we want to assess whether subclinical cardiovascular damage is present in adult patients
with breast cancer who have completed treatment with (neo)adjuvant TAC one year previously,
using MIBG (meta-iodobenzylguanidine) scintigraphy, novel echocardiographic techniques and
blood biomarkers. Following the study by Lipshultz et al. we expect to find at least in 25%
of the patients signs of subclinical cardiovascular damage with at least one of the three
techniques.(11) If at least 10% is observed we will conclude that it is useful to further
pursue the use of these techniques for the detection of subclinical cardiotoxicity in a next
clinical study which will be powered to assess the predictive value of these techniques for
the development of clinical heart failure. If a lower percentage is observed we will
conclude that it is not useful to further pursue the use of these techniques for the
detection of subclinical cardiotoxicity.
Observational
Observational Model: Cohort
H.W.M. van Laarhoven, Md
Principal Investigator
University Medical Centre Nijmegen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
UMCNONCO201005
NCT01246856
November 2010
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