Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ultrasound
- description
- The group of women who are being followed by Ultrasound.
- interventionNames
- Procedure: Ultrasound
Primary outcomes (1)
- measure
- Determine the volume change in lumpectomy cavity during the course of external beam radiation prior to delivery of the radiation boost.
- timeFrame
- 7 weeks
Secondary outcomes (1)
- measure
- Determine by daily ultrasound if targeting of the CT-based boost field is inaccurate due to daily variation of subject position.
- timeFrame
- 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDJacobson G, Betts V, Smith B. Change in volume of lumpectomy cavity during external-beam irradiation of the intact breast. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1161-4. doi: 10.1016/j.ijrobp.2006.02.009. Epub 2006 May 6. PMID 16682143
- BACKGROUNDWarszawski A, Baumann R, Karstens JH. Sonographic guidance for electron boost planning after breast-conserving surgery. J Clin Ultrasound. 2004 Sep;32(7):333-7. doi: 10.1002/jcu.20050. PMID 15293299
- BACKGROUNDGilligan D, Hendry JA, Yarnold JR. The use of ultrasound to measure breast thickness to select electron energies for breast boost radiotherapy. Radiother Oncol. 1994 Sep;32(3):265-7. doi: 10.1016/0167-8140(94)90026-4. PMID 7816945
- BACKGROUNDLeonard C, Harlow CL, Coffin C, Drose J, Norton L, Kinzie J. Use of ultrasound to guide radiation boost planning following lumpectomy for carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1193-7. doi: 10.1016/0360-3016(93)90543-5. PMID 8262847