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Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts (MBI-DBT)

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ClinicalTrials.gov Identifier: NCT03220893
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic

Brief Summary:
The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts. This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique. These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers that remain occult on anatomic techniques. This study will also provide exploratory data about the optimal frequency of repeat MBI.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Molecular Breast Imaging Diagnostic Test: Digital Breast Tomosynthesis

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women with Dense Breast Tissue

Subjects will have had heterogeneously dense or extremely dense breasts on most recent prior mammographic examination (Breast Imaging Reporting and Data System (BI-RADS) c or d) and be asymptomatic for breast disease.

Subjects will receive Molecular Breast Imaging (MBI) and Digital Breast Tomosynthesis (DBT) at Year 0 screening within a 24-hour period. All patients who did not receive a diagnosis of breast cancer during the Year 0 screening will undergo DBT and MBI at approximately one year (Year 1 screening), again within a 24-hour period.

Diagnostic Test: Molecular Breast Imaging
Molecular breast imaging (MBI) is a new nuclear medicine technique that utilizes small semiconductor-based γ-cameras in a mammographic configuration to provide high-resolution functional images of the breast.

Diagnostic Test: Digital Breast Tomosynthesis
Digital Breast Tomosynthesis (DBT) creates a three dimensional picture of the breast using X-rays.




Primary Outcome Measures :
  1. Rate of detection of invasive cancers between DBT and MBI at Year 0 using the biopsy results (if available) and one-year follow-up results as the reference standard. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants are being studied
Sampling Method:   Non-Probability Sample
Study Population
Potentially eligible patients who are scheduled for a screening DBT will be prescreened based on their breast density on past prior mammogram.
Criteria

Inclusion Criteria:

  1. Patient is a consenting female age 40-75 years scheduled for routine screening DBT.
  2. Patient is asymptomatic for breast disease.
  3. Patient had heterogeneously dense or extremely dense breasts on most recent prior mammographic examination (BI-RADS c or d).
  4. Patient is able to participate fully in all aspects of the study (completing study visits and study data collection).
  5. Patient understands and signs the study informed consent.
  6. Patient anticipates being able to return one year after study enrollment to complete the second round of screening.

Exclusion Criteria:

  1. Prior MBI.
  2. Prior whole breast ultrasound (WBUS), with either a hand-held ultrasound probe or automated system. A prior diagnostic breast ultrasound is not an exclusion criteria.
  3. Prior contrast-enhanced breast MRI.
  4. Prior contrast-enhanced mammogram (CESM or CEDM).
  5. Concurrent participation in any other breast imaging research studies that involve undergoing additional imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI.
  6. Patient is pregnant or lactating.
  7. Patient had a breast biopsy within 3 months prior to study enrollment.
  8. Patient had breast surgery within 12 months prior to study enrollment.
  9. Patient is using endocrine therapy for breast cancer treatment or prevention.
  10. Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220893


Contacts
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Contact: Tamara K Evans 507-266-1944 RSTDOMCTU@mayo.edu
Contact: Peggy Nordine 507-266-1944 RSTDOMCTU@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamara K Evans    507-266-1944    RSTDOMCTU@mayo.edu   
Contact: Peggy Nordine    507-266-1944    RSTDOMCTU@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Deborah Rhodes, MD Mayo Clinic

Additional Information:
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Responsible Party: Deborah Rhodes, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03220893     History of Changes
Other Study ID Numbers: 16-008522
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No