Early Stage Breast CancerNCT01166581
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates
An observational study of Early Stage Breast Cancer, run by Summa Health System at 1 site in United States.
Trial summary
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2015
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: early stage breast cancer cases between 2006-2009
Who may be able to join
- early stage breast cancer between 2006-2009
- preoperative MRI
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm.
The objectives are to:
- Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
- Determine the results of preoperative breast MRI and the impact on type of surgery performed
- Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or patient decision and if this decision was based on breast MRI findings
Read the detailed description
Early stage breast cancer cases between 2006 and 2009 will be identified by the Summa Akron City Hospital cancer registry. The cases will be reviewed and abstracted. The abstracted data will include results of physical breast examinations, mammograms, sonograms, breast MRI reports, biopsy procedure notes and pathology reports to illustrate the clinical stage. Definitive surgical pathology reports will be included in the abstracted data to demonstrate the final pathologic stage of the breast cancer.
A database will be developed to capture the abstracted data. Outcomes will be determined based on final pathology reports.
- Conditions
- Early Stage Breast Cancer
- Keywords
- early stage breast cancer, preoperative breast MRI, mastectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital.
Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
Determine the results of preoperative breast MRI and the impact on type of surgery performed
Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer.
Measured: from 2006-2009
Secondary outcomes (1)
Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer
Measured: 2006-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Not enough data collected to work with
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Desiree Doncals, MD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166581
- Sponsor's protocol ID
- Doncals Breast MRI study
- Status last verified
- Feb 2015
- First submitted
- 19 Jul 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Del Frate C, Borghese L, Cedolini C, Bestagno A, Puglisi F, Isola M, Soldano F, Bazzocchi M. Role of pre-surgical breast MRI in the management of invasive breast carcinoma. Breast. 2007 Oct;16(5):469-81. doi: 10.1016/j.breast.2007.02.004. Epub 2007 Apr 12.
PubMed 17433681Ciocchetti JM, Joy N, Staller S, Warmack J, Mann A, Moore JT, Davis-Merritt DK. The effect of magnetic resonance imaging in the workup of breast cancer. Am J Surg. 2009 Dec;198(6):824-8. doi: 10.1016/j.amjsurg.2009.05.029.
PubMed 19969136
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital
- ClinicalTrials.gov ID
- NCT01166581
- Acronym / sponsor ID
- Doncals Breast MRI study
- Conditions
- Early Stage Breast Cancer
- Keywords
- early stage breast cancer, preoperative breast MRI, mastectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough data collected to work with
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Jul 2010 (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.
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm.
The objectives are to:
- Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
- Determine the results of preoperative breast MRI and the impact on type of surgery performed
- Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or patient decision and if this decision was based on breast MRI findings
Detailed description
Early stage breast cancer cases between 2006 and 2009 will be identified by the Summa Akron City Hospital cancer registry. The cases will be reviewed and abstracted. The abstracted data will include results of physical breast examinations, mammograms, sonograms, breast MRI reports, biopsy procedure notes and pathology reports to illustrate the clinical stage. Definitive surgical pathology reports will be included in the abstracted data to demonstrate the final pathologic stage of the breast cancer.
A database will be developed to capture the abstracted data. Outcomes will be determined based on final pathology reports.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- early stage breast cancer cases between 2006-2009
Key inclusion criteria (2 listed)
- early stage breast cancer between 2006-2009
- preoperative MRI
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital.
Time frame: from 2006-2009
Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging Determine the results of preoperative breast MRI and the impact on type of surgery performed Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer.
1 secondary outcome
Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer
Time frame: 2006-2009
Results and safety
The study was stopped early (reason given: Not enough data collected to work with). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Background: PubMed 17433681Del Frate C, Borghese L, Cedolini C, Bestagno A, Puglisi F, Isola M, Soldano F, Bazzocchi M. Role of pre-surgical breast MRI in the management of invasive breast carcinoma. Breast. 2007 Oct;16(5):469-81. doi: 10.1016/j.breast.2007.02.004. Epub 2007 Apr 12.
- Background: PubMed 19969136Ciocchetti JM, Joy N, Staller S, Warmack J, Mann A, Moore JT, Davis-Merritt DK. The effect of magnetic resonance imaging in the workup of breast cancer. Am J Surg. 2009 Dec;198(6):824-8. doi: 10.1016/j.amjsurg.2009.05.029.
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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.
Desiree Doncals, MD principal investigator
Summa Health System
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 Early Stage Breast Cancer, run by Summa Health System 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Feb 2015. 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 was stopped early (reason given: Not enough data collected to work with). Results are not available in the source record.
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?
The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital. (time frame: from 2006-2009). 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 NCT01166581, which also lists 2 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 4 Feb 2015.