Breast CancerNCT01723124
Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up
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 research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Molecular Breast Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2014
- 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 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
Who cannot join
- Subjects will be excluded if they:
- Are unable to understand and sign the consent form
- Are pregnant or lactating
- Are physically unable to sit upright and still for 40 minutes
- Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
Show all 9Show fewer
- Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
- Have undergone bilateral mastectomy
- Have had a prior MBI within 20 months of scheduled study MBI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.
- Conditions
- Breast Cancer
- Being tested
- Molecular Breast Imaging
- Keywords
- Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer, breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Breast ImagingProcedure or surgery
Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.
| Study group | Role | What they receive |
|---|---|---|
| Molecular Breast Imaging | Experimental | Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors. Receives: Procedure: Molecular Breast Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Breast Imaging (MBI) scan
The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
Measured: Performed at Year 0 of study
Secondary outcomes (1)
Molecular Breast Imaging (MBI) scan
The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.
Measured: Performed at Year 2 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Dose specified in protocol was not adequate to achieve optimal resolution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Rhodes, Mayo Clinic
- Investigators
- Deborah Rhodes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723124
- Sponsor's protocol ID
- 12-004322
- Status last verified
- Sep 2016
- First submitted
- 24 Jul 2012
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
PubMed 21045179
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
- ClinicalTrials.gov ID
- NCT01723124
- Acronym / sponsor ID
- 12-004322
- Conditions
- Breast Cancer
- Keywords
- Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer, breast
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dose specified in protocol was not adequate to achieve optimal resolution.
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Nov 2012 (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 research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular Breast Imaging | Experimental | Procedure: Molecular Breast ImagingMolecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
Key exclusion criteria (9 listed)
- Are unable to understand and sign the consent form
- Are pregnant or lactating
- Are physically unable to sit upright and still for 40 minutes
- Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
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 (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors. | Procedure or surgery | Molecular Breast Imaging |
Primary outcome
Molecular Breast Imaging (MBI) scan
Time frame: Performed at Year 0 of study
The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
1 secondary outcome
Molecular Breast Imaging (MBI) scan
Time frame: Performed at Year 2 of study
Results and safety
The study was stopped early (reason given: Dose specified in protocol was not adequate to achieve optimal resolution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Background: PubMed 21045179Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
- Mayo Clinic You Tube ChannelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Deborah Rhodes, MD principal investigator
Mayo Clinic
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 1 inclusion and 9 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 21 Sep 2016. 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: Dose specified in protocol was not adequate to achieve optimal resolution.). 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?
Molecular Breast Imaging (MBI) scan (time frame: Performed at Year 0 of study). 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 NCT01723124, which also lists 1 linked publication.
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 21 Sep 2016.