Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 8/18/2018 |
| Start Date: | June 12, 2017 |
| End Date: | June 30, 2020 |
| Contact: | Tamara K Evans |
| Email: | RSTDOMCTU@mayo.edu |
| Phone: | 507-266-1944 |
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.
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.
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.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-266-1944
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