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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 15, 2017
First Posted Date July 18, 2017
Last Update Posted Date May 8, 2019
Actual Study Start Date June 12, 2017
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03220893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts
Official Title Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Cancer
Intervention
  • 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.
Study Groups/Cohorts 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.

Interventions:
  • Diagnostic Test: Molecular Breast Imaging
  • Diagnostic Test: Digital Breast Tomosynthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2017)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female participants are being studied
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Tamara K Evans 507-266-1944 RSTDOMCTU@mayo.edu
Contact: Peggy Nordine 507-266-1944 RSTDOMCTU@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03220893
Other Study ID Numbers 16-008522
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Deborah Rhodes, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Deborah Rhodes, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2019