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The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes With Myocardial Perfusion, Cardiac Function, Metabolism and Clinical Prognosis.


N/A
20 Years
80 Years
Open (Enrolling)
Female
Breast Cancer, Female

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Trial Information

The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes With Myocardial Perfusion, Cardiac Function, Metabolism and Clinical Prognosis.


- Inclusion Criteria:

1. Female patients with breast cancer who scheduled further regional RT. Groups of
left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer
(conventional RT).

2. Aged 20-80 years old.

- Exclusion Criteria

1. Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD,
congestive heart failure.

2. Pregnancy

3. Any medical contraindication of cardiac SPECT.

- Estimated Case Number 20 female patients of each groups, respectively Group 1:
Left-sided breast cancer, planning to received helical tomography Group 2: Left-sided
breast cancer, planning to received local conventional RT Group 3: Right-sided breast
cancer, planning to received local RT

1. Patients with breast cancer s/p operation will be transferred to CV OPD for
initial cardiovascular risk factors assessment.

2. Past history, family history, basic lab data and Framingham cardiovascular risk
assessment will be applied. Intermediated to high risk need further work-up, and
undergo SPECT before further RT course.

3. All enrolled subjects provide basic demographic data and sign informed consents.

4. Myocardial perfusion images for baseline evaluation before RT.

5. The patients received scheduled treatment plan, including RT.

6. Follow-up CV OPD every 3 months.

7. Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.

8. Comparing the clinical follow-up data between groups, including global functional
assessments, blood sampling data, myocardial perfusion scan, and quantitative
cardiac functional parameters.

Blood sampling

Myocardial perfusion study- Patients referred for SPECT MPI for evaluation of CAD underwent
a 1-day Tl-201 stress/rest MPI protocol, as daily practice in FEMH. Pharmacological stress
was induced by standard dipyridomale infusion. Tl-201 of 2 mCi was injected after 7 min of
induced stress. Each scan will be performed on an ultrafast CZT camera (Discovery 530 NMc,
GE Healthcare). CZT images were reconstructed on the workstation using a dedicated iterative
algorithm with maximum likelihood expectation maximization. Perfusion images in standard
axis (short axis, vertical long axis, horizontal long axis) and polar maps of the left
ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers
blinded to any information on patient identification.

The software package with a 17-segment model for the left ventricle. Automated analysis of
gated acquisitions from high-dose (rest) scans was performed to determine left ventricular
ejection fraction. Integrated clinical information, follow-up and nuclear medicine cardiac
scans performed in the time points of before & after RT will be collected and analyzed.


Inclusion Criteria:



- Female patients with breast cancer who scheduled further regional RT. Groups of
left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer
(conventional RT).

- Aged 20-80 years old.

Exclusion Criteria:

- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD,
congestive heart failure.

- Pregnancy

- Any medical contraindication of cardiac SPECT.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images

Outcome Description:

By literature reviewing, cardiovascular functional status in patients received helical tomography has not been fully investigated yet. And the post-therapeutic heart disease tends to show a wide spectrum of pathologies and multiple risk factors. We will monitor risk factors of underlying disease, family history, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineation of RT-related effects and clinical prognosis.

Outcome Time Frame:

Dec, 2013 (after 12 months of baseline study).

Safety Issue:

No

Principal Investigator

Shan-Ying Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Far Eastern Memorial Hospital, Taiwan

Authority:

Taiwan: Department of Health

Study ID:

FEMH-IRB-101085-F

NCT ID:

NCT01758419

Start Date:

December 2012

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer, Female
  • post-RT
  • myocardial perfusion images
  • Breast Neoplasms

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