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Status unknownNCT01018719Updated Nov 25, 2009

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

An observational study in Breast Cancer, sponsored by Western Galilee Hospital-Nahariya. Status unknown. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-11-25.

Sponsored by Western Galilee Hospital-Nahariya · Observational

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 60 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer radiotherapy cardiotoxicity multidetector CT
  • Radiotherapy
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In context

Cardiotoxicity

264 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 125 observational studies indexed under Cardiotoxicity.

Browse Cardiotoxicity studies →

Lead sponsor

Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with breast cancer followed in the oncology clinic.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)

Groups and cohorts

  • Left side breast cancer

    Device: MDCT, ECG, Echocardiography

  • Right side breast cancer

    Device: MDCT, ECG, Echocardiography

Interventions

  • DeviceMDCT, ECG, Echocardiography

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

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What researchers measure

Primary outcomes

  1. Degree of damage to the coronary arteries as measured by MDCT

    Time frame: 5 to 15 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01018719
Lead sponsor
Western Galilee Hospital-Nahariya
Collaborators
Rambam Health Care Campus
First posted
Nov 25, 2009
Start date
Jan 2010
Primary completion
Dec 2011 (estimated)
Last update
Nov 25, 2009

Study contacts

Hadassah Goldberg, MD
Contact
hadassah.goldberg@naharia.health.gov.il
972-4-9103482
Moshe Goldfeld, MD
Contact
moshe.goldfeld@naharia.health.gov.il
972-4-9107563
Hadassah Goldberg, MD
principal investigator · Oncology center, Western Galilee Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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