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

December 20, 2007
December 31, 2007
January 16, 2014
June 2006
April 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00583843 on Archive Site
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 ]
Same as current
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Ultrasound Targeting for the Lumpectomy Cavity
Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost Dose
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.

Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Women and men who have had lumpectomy for the definitive treatment of breast cancer and have a defined cavity from this procedure.
Breast Neoplasms
Procedure: Ultrasound
Ultrasound weekly during initial fields of radiation, and daily during the boost phase.
The group of women who are being followed by Ultrasound.
Intervention: Procedure: Ultrasound

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2011
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Jacobson, Geraldine M, University of Iowa
University of Iowa
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Principal Investigator: Geraldine Jacobson, MD MPH The Department of Radiation Oncology
University of Iowa
January 2014