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Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer


The primary objective of this study is to estimate the rate of radiation-associated regional
myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH
for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac
perfusion scans pre- and 6 months post-radiation.


Inclusion Criteria:



- signed an Institutional Review Board (IRB)-approved informed consent document for
protocol

- age >= 18 years

- histologically confirmed left-sided breast cancer scheduled to undergo curative
intent radiation treatment post lumpectomy or mastectomy

- stage 0-III left-sided breast cancer (including DCIS)

- SPECT score of 0 at baseline

- radiation oncologist agrees target volume coverage will not be compromised via use of
the DIBH technique along with conformal field shaping

Exclusion Criteria:

- active cardiac disease, defined as a history of angina, arrhythmias, myocardial
infarction, congestive heart failure, or any other cardiac condition, which in the
opinion of the treating physician would make this protocol unreasonably hazardous for
the patient

- symptomatic pulmonary disease currently requiring regular medication including but
not restricted to bronchodilators

- concurrent chemotherapy

- prior receipt of mediastinal radiation therapy

- pregnant or lactating women

- inability to understand and follow breathing instructions for the DIBH procedure

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes in cardiac perfusion

Outcome Description:

Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) > 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.

Outcome Time Frame:

6-months post radiation

Safety Issue:

No

Principal Investigator

Timothy M Zagar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

LCCC1239

NCT ID:

NCT01849614

Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North Carolina  27599