Evaluation of Radiation Induced Toxicity to the Heart by Multi-detector Computed Tomography (MDCT)

NCT ID: NCT01018719

Last Updated: 2009-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31

Brief Summary

The current study is aimed to evaluate various imaging methods, including multidetector computed tomography (MDCT) as potential surrogates to assess the degree of damage caused to the heart by radiation therapy to the breast, in breast cancer survivors many years before it becomes clinically apparent.

Detailed Description

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.

Conditions

Breast Cancer

Keywords

breast cancer radiotherapy cardiotoxicity multidetector CT; Radiotherapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Left side breast cancer

MDCT, ECG, Echocardiography

Intervention Type: DEVICE

Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.

Right side breast cancer

MDCT, ECG, Echocardiography

Intervention Type: DEVICE

Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.

Interventions

MDCT, ECG, Echocardiography

Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: collaborator

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

oncology unit, Western Galilee Hospital, Nahariya, Israel

Principal Investigators

Hadassah Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology center, Western Galilee Hospital

Central Contacts

Hadassah Goldberg, MD

Role: CONTACT

Phone: 972-4-9103482

Email: hadassah.goldberg@naharia.health.gov.il

Moshe Goldfeld, MD

Role: CONTACT

Phone: 972-4-9107563

Email: moshe.goldfeld@naharia.health.gov.il

Other Identifiers

cardiotoxicity66809

Identifier Type: -

Identifier Source: org_study_id