Breast CancerMBINCT00591864
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
A study testing Molecular Breast Imaging in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Molecular Breast Imaging
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.
- Patients must not be lactating or pregnant.
- All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.
- women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).
Who cannot join
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes.
- The breast MRI is for screening purposes or to determine the status of breast augmentation.
- They have undergone breast surgery within the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
Read the detailed description
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.
Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.
Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.
Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.
- Conditions
- Breast Cancer
- Being tested
- Molecular Breast Imaging
- Keywords
- Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Breast ImagingDevice
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity on the Per Patient Level
Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.
Measured: within 1 week of surgery or biopsy
Secondary outcomes (2)
Sensitivity on the Per Tumor Level
Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
Measured: within 1 week of surgery or biopsy
Specificity
The number of women with negative imaging test per number of women without cancer.
Measured: at least one year following imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Amy L. Conners, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591864
- Sponsor's protocol ID
- 07-003397
- Acronym
- MBI
- Status last verified
- Jun 2014
- First submitted
- 21 Dec 2007
- Last updated
- 9 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
- ClinicalTrials.gov ID
- NCT00591864
- Acronym / sponsor ID
- MBI / 07-003397
- Conditions
- Breast Cancer
- Keywords
- Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 9 Jul 2014
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 the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
Detailed description
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.
Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.
Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.
Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.
- Patients must not be lactating or pregnant.
- All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.
- women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).
Key exclusion criteria (5 listed)
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes.
- The breast MRI is for screening purposes or to determine the status of breast augmentation.
- They have undergone breast surgery within the previous year
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 |
|---|---|---|
| Molecular Breast ImagingMolecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors. | Device | – |
Primary outcome
Sensitivity on the Per Patient Level
Time frame: within 1 week of surgery or biopsy
Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.
2 secondary outcomes
Sensitivity on the Per Tumor Level
Time frame: within 1 week of surgery or biopsy
Specificity
Time frame: at least one year following imaging
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic You Tube ChannelLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular Breast Imaging in people with Breast Cancer, run by Mayo Clinic 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 4 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 9 Jul 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?
Yes. Results are posted in the registry (first posted 9 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity on the Per Patient Level (time frame: within 1 week of surgery or biopsy). 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 9 Jul 2014.