Ultrasound Targeting for the Lumpectomy Cavity
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
|
Mastectomy, Segmental |
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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2012 |
| 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 |
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.
Contacts and Locations| United States, Iowa | |
| The University of Iowa Hospitals & Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| Principal Investigator: | Geraldine Jacobson, MD MPH | The Department of Radiation Oncology |
More Information
Publications:
| Responsible Party: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00583843 History of Changes |
| Other Study ID Numbers: | 200602784 |
| Study First Received: | December 20, 2007 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Lumpectomy Ultrasonography Radiotherapy |
ClinicalTrials.gov processed this record on June 17, 2013