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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01018719
Recruitment Status : Unknown
Verified November 2009 by Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by:
Western Galilee Hospital-Nahariya

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Device: MDCT, ECG, Echocardiography

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Radiation Induced Cardiotoxicity by Multi-detector Computed Tomography (MDCT)
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Groups and Cohorts
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Group/Cohort Intervention/treatment
Left side breast cancer Device: MDCT, ECG, Echocardiography
Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.
Right side breast cancer Device: MDCT, ECG, Echocardiography
Multi-detector computed tomography to evaluate coronary artery patency; ECG and Echocardiography - to evaluate cardiac function.


Outcome Measures
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Primary Outcome Measures :
  1. Degree of damage to the coronary arteries as measured by MDCT [ Time Frame: 5 to 15 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breast cancer followed in the oncology clinic.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018719


Contacts
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Contact: Hadassah Goldberg, MD 972-4-9103482 hadassah.goldberg@naharia.health.gov.il
Contact: Moshe Goldfeld, MD 972-4-9107563 moshe.goldfeld@naharia.health.gov.il

Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Rambam Health Care Campus
Investigators
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Principal Investigator: Hadassah Goldberg, MD Oncology center, Western Galilee Hospital
More Information
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Responsible Party: Dr. Hadassah Goldberg, Director oncology unit, oncology unit, Western Galilee Hospital, Nahariya, Israel
ClinicalTrials.gov Identifier: NCT01018719    
Other Study ID Numbers: cardiotoxicity66809
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Western Galilee Hospital-Nahariya:
breast cancer radiotherapy cardiotoxicity multidetector CT
Radiotherapy
Additional relevant MeSH terms:
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Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries