Breast NeoplasmsNCT00583843
Ultrasound Targeting for the Lumpectomy Cavity
An observational study of Breast Neoplasms, run by University of Iowa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women and men who have had lumpectomy for the definitive treatment of breast cancer and have a defined cavity from this procedure.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Ultrasound
- Keywords
- Lumpectomy, Ultrasonography, Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound weekly during initial fields of radiation, and daily during the boost phase.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | The group of women who are being followed by Ultrasound. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the volume change in lumpectomy cavity during the course of external beam radiation prior to delivery of the radiation boost.
Measured: 7 weeks
Secondary outcomes (1)
Determine by daily ultrasound if targeting of the CT-based boost field is inaccurate due to daily variation of subject position.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startJun 2006
- Primary completionApr 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobson, Geraldine M, University of Iowa
- Investigators
- Geraldine Jacobson, MD MPH, Principal investigator, The Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583843
- Sponsor's protocol ID
- 200602784
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2007
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacobson 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.
PubMed 16682143Warszawski 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.
PubMed 15293299Gilligan 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.
PubMed 7816945Leonard 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.
PubMed 8262847
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Change in the Lumpectomy Cavity During Radiation Therapy by Weekly Ultrasound and by Daily Ultrasound During the Radiation Boost Dose
- ClinicalTrials.gov ID
- NCT00583843
- Acronym / sponsor ID
- 200602784
- Conditions
- Breast Neoplasms
- Keywords
- Lumpectomy, Ultrasonography, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | Procedure: UltrasoundThe group of women who are being followed by Ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men who have had lumpectomy for the definitive treatment of breast cancer and have a defined cavity from this procedure.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound weekly during initial fields of radiation, and daily during the boost phase. | Procedure or surgery | Ultrasound |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
- Background: PubMed 16682143Jacobson 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.
- Background: PubMed 15293299Warszawski 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.
- Background: PubMed 7816945Gilligan 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.
- Background: PubMed 8262847Leonard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Jacobson, MD MPH principal investigator
The Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583843, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.