Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-008522
    • La Crosse, Wisconsin: 16-008522
    NCT ID: NCT03220893
    Sponsor Protocol Number: 16-008522

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Patient is a consenting female age 40-75 years.
  • Patient is scheduled for routine screening DBT.
  • Patient is asymptomatic for breast disease.
  • Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (BI-RADS c or d) within 24 months of enrollment.
  • Patient is able to participate fully in all aspects of the study (completing study visits and study data collection).
  • Patient understands and signs the study informed consent.
  • Patient anticipates being able to return one year after study enrollment to complete the second round of screening.

Exclusion Criteria:

  • Patient is currently pregnant or plans to become pregnant during the course of the study.
  • Patient is currently lactating.
  • Patient has had a prior MBI.
  • Patient has had a prior WBUS, with either a hand-held ultrasound probe or automated system.A prior diagnostic breast ultrasound is not an exclusion criterion.
  • Patient has had a prior breast MRI.
  • Patient has had a prior contrast-enhanced mammogram (CESM or CEDM).
  • Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI.
  • Patient has had a breast biopsy within 3 months prior to study enrollment.
  • Patient has had breast surgery within 12 months prior to study enrollment.
  • Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (ADH, ALH, LCIS, papilloma, radial scar).
  • Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane).
  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Deborah Rhodes, M.D.

Open for enrollment

Contact information:

Chelsie VanOort

(507)266-3912

VanOort.Chelsie@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Deborah Rhodes, M.D.

Open for enrollment

Contact information:

Leandra Pake

(608)392-9719

Franzen.Leandra@mayo.edu

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CLS-20310394

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