Accurate targeting of treatment sites should increase local control by radiation therapy for
breast-cancer lumpectomy patients. Currently, ultrasound localization is used for prostate
cancer patients to locate the prostate before daily radiation treatments. There is now
documented evidence that the lumpectomy site does change during the external radiation
therapy. Thus, treatment efficacy should be increased by localizing the target, monitoring
volume changes, and adjusting the radiation target prior to the boost radiation dose.
Study participants will have weekly ultrasounds performed of the lumpectomy cavity to
determine shift and volume changed from the initial treatment-planning CT to the time of the
radiation boost (approximately 4 weeks). These ultrasounds are done prior to their weekly
doctor's appointment with Radiation Oncology.
When it is time to perform the radiation boost (when the radiation is more targeted to the
lumpectomy cavity), the ultrasound will be done daily with the participant in treatment
position. The SonArray system used for the ultrasound-driven targeting for prostate cancer
will be utilized. If the lumpectomy cavity is observed, the ultrasound suggested shifts will
be noted and compared to the shifts needed for standard clinical set up.
Once the subject has completed radiation therapy, the study participation is complete.
- Ability to understand and the willingness to sign a written informed consent
- Patients must have histologically or cytologically confirmed breast carcinoma with
voluntarily elected breast conservation techniques (i.e., lumpectomy)
- Age >18 years. Breast cancer, while not restricted only to adult women, is rare in
the younger population.
- Radiation indicated as a post-surgical adjuvant treatment for breast conservation.
- Life expectancy of greater than 6 months.
- Karnofsky of greater or equal to 60
- The effects of radiation therapy on the developing human fetus at the recommended
therapeutic dose can be abortifacient. For this reason, and because radiation
therapy is known to be teratogenic, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation. Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately.
- Patients who have not recovered from adverse events due to agents administered more
than 4 weeks earlier.
- The inability to visualize or reliably contour the lumpectomy cavity from the
Radiation Oncology treatment planning CT scan.
- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements in the opinion of the principal investigator.
- Pregnant women are excluded from this study because radiation therapy has the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with standard chemotherapeutic regimens (if applicable), breastfeeding should
be discontinued if the mother is treated any adjuvant chemotherapy.