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Evaluation of Radiation Induced Cardiotoxicity by Multi-detector Computed Tomography (MDCT)

18 Years
60 Years
Not Enrolling
Breast Cancer

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Trial Information

Evaluation of Radiation Induced Cardiotoxicity by Multi-detector Computed Tomography (MDCT)

Early detection and improved treatment approaches following breast cancer (BC) have
increased disease specific survival and resulted in increasing cohorts of BC survivors who
are prone to develop late complications from treatment, including damage caused by radiation
therapy (RT) to the heart. Older RT techniques for treating the breast resulted in excess
cardiovascular morbidity and mortality. Improved RT techniques minimize irradiation to the
heart. Data from various trials have yielded conflicting results on the extent to which
these contemporary techniques have actually decreased cardiotoxicity. Long term follow-up
and large cohorts are needed in order to evaluate the risk for cardiotoxicity, when based on
its clinical manifestations. The current study is aimed to evaluate various imaging methods
as potential surrogates to assess the degree of damage caused to the heart by RT in BC
survivors many years before it becomes clinically apparent.This includes Multi-detector
computed tomography (MDCT) - based on high resolution computed tomography of the heart
following injection of contrast medium which evaluates the degree of stenosis of the
coronary arteries.

One hundred patients treated for breast carcinoma, fifty with left breast and fifty with
right breast cancer, will be included in the current study and compared for the incidence of
cardiac damage. Since the radiation dose to the heart is substantially lower in patients
irradiated for right-sided tumors, comparing the incidence of findings indicating cardiac
injury in the two groups will define the contribution of RT to these findings. For each
patient included in the study, the incidence of cardiovascular disease will be correlated
also with the volume of heart irradiated, the radiation dose delivered to that volume, the
concomitant administration of cardiotoxic systemic agents, as well as to patient's age when
irradiated and risk factors for developing coronary artery disease.

Inclusion Criteria:

1. Patients who were diagnosed with early breast cancer, histologically proven. Both
invasive and non invasive histologies will be included.

2. The study will include patients, who underwent a definitive surgery - either breast
conserving or mastectomy - and received radiation therapy to the breast or to the
chest wall respectively +/- to lymphatic drainage.

3. No evidence of recurrence of their malignancy or any other malignant disease.

4. Age at diagnosis and radiation to the breast will not exceed 60 years.

5. Signed informed consent by the patient will be mandatory.

Exclusion Criteria:

1. As MDCT requires injection of contrast media, Patients with contra indications for
injection of contrast media, due to either a history of allergic reaction or renal
insufficiency, will be excluded of the study.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Degree of damage to the coronary arteries as measured by MDCT

Outcome Time Frame:

5 to 15 years

Safety Issue:


Principal Investigator

Hadassah Goldberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology center, Western Galilee Hospital


Israel: Ministry of Health

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer radiotherapy cardiotoxicity multidetector CT
  • Radiotherapy
  • Breast Neoplasms