Ultrasound Targeting for the Lumpectomy Cavity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jacobson, Geraldine M, University of Iowa
ClinicalTrials.gov Identifier:
NCT00583843
First received: December 20, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention
Breast Neoplasms
Procedure: Ultrasound

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ultrasound
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583843

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

Publications:
Responsible Party: Jacobson, Geraldine M, Adjunct Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00583843     History of Changes
Other Study ID Numbers: 200602784
Study First Received: December 20, 2007
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Lumpectomy
Ultrasonography
Radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014