Breast CancerBSMARTNCT00948285
Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer
A study testing MRI in people with Breast Cancer, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2018
- Phase
- Interventional
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed breast cancer patients
- Breast cancer patients identified as conservation candidates by their surgeons
Who cannot join
- Patients with a history of prior breast cancer treatment (recurrence)
- Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)
- Patients with documented sensitivity to gadolinium (contrast agent used during MRI)
- Patients who weigh more than 350 pounds (weight limit on MRI machine)
- Patients who receive neoadjuvant chemotherapy
- Patients with renal insufficiency (serum Cr > 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
About this study
Official title: Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.
Read the detailed description
We propose that the role of preoperative staging-MRI in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. The need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. We propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of MRI. In addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. The visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 Since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. Hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. The index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- breast cancer, magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
magnetic resonance imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200) Receives: Procedure: MRI |
| Non-MRI | No intervention | Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2018
- Study completionDec 2018
Why it stopped: Difficult accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakhshanda L Rahman, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948285
- Sponsor's protocol ID
- A09-3519
- Acronym
- BSMART
- Status last verified
- Nov 2019
- First submitted
- 27 Jul 2009
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
- ClinicalTrials.gov ID
- NCT00948285
- Acronym / sponsor ID
- BSMART / A09-3519
- Conditions
- Breast Cancer
- Keywords
- breast cancer, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult accrual
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Jul 2009 (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 purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.
Detailed description
We propose that the role of preoperative staging-MRI in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. The need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. We propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of MRI. In addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. The visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 Since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. Hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. The index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Procedure: MRIPreoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200) |
| Non-MRI | No intervention | –Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed breast cancer patients
- Breast cancer patients identified as conservation candidates by their surgeons
Key exclusion criteria (6 listed)
- Patients with a history of prior breast cancer treatment (recurrence)
- Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)
- Patients with documented sensitivity to gadolinium (contrast agent used during MRI)
- Patients who weigh more than 350 pounds (weight limit on MRI machine)
- Patients who receive neoadjuvant 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 |
|---|---|---|
| MRImagnetic resonance imaging (MRI) | Procedure or surgery | MRI |
Primary outcome
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Difficult accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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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.
Rakhshanda L Rahman, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Breast Cancer, run by Texas Tech University Health Sciences Center 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 6 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 13 Nov 2019. 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: Difficult accrual). 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?
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.