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Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost Dose

18 Years
Open (Enrolling)
Mastectomy, Segmental

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Trial Information

Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost 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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Determine the volume change in lumpectomy cavity during the course of external beam radiation prior to delivery of the radiation boost.

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Geraldine Jacobson, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Department of Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Mastectomy, Segmental
  • Lumpectomy
  • Ultrasonography
  • Radiotherapy



The University of Iowa Hospitals & Clinics Iowa City, Iowa  52242