Ultrasound Targeting for the Lumpectomy Cavity

Completed

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00583843

Run by

University of Iowa

People needed

20

Starts

2006-06-01

Expected to finish

2011-12-01

Last updated by the study team

2014-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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