Ultrasound Targeting for the Lumpectomy Cavity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583843
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):
Jacobson, Geraldine M, University of Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Neoplasms Procedure: Ultrasound

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost Dose
Study Start Date : June 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
The group of women who are being followed by Ultrasound.
Procedure: Ultrasound
Ultrasound weekly during initial fields of radiation, and daily during the boost phase.

Primary Outcome Measures :
  1. Determine the volume change in lumpectomy cavity during the course of external beam radiation prior to delivery of the radiation boost. [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Determine by daily ultrasound if targeting of the CT-based boost field is inaccurate due to daily variation of subject position. [ Time Frame: 7 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women and men who have had lumpectomy for the definitive treatment of breast cancer and have a defined cavity from this procedure.

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document.
  • 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 events.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583843

United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Principal Investigator: Geraldine Jacobson, MD MPH The Department of Radiation Oncology