An interventional study of 2-dimensional mammogram and digital breast tomosynthesis (DBT) in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.
Primary Objective:
The primary objective of the study is to measure the frequency with which DBT alters the surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional site of cancer or DCIS, will be taken into account when estimating the frequency of changes to surgical management.
Secondary objectives:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram
Device: 2-dimensional mammogram · Device: digital breast tomosynthesis (DBT)
This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
Also known as: 3-dimensional mammogram
Number of Participants for Which DBT Altered Surgical Plan
Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management
Time frame: At completion of 3-Dimensional mammogram (1 day)
Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT
Time frame: At completion of 3-Dimensional mammogram (1 day)
The Proportion of Patients Undergoing Additional Work-up Following the DBT
Time frame: At completion of 3-Dimensional mammogram (1 day)
Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings
Time frame: At completion of 3-Dimensional mammogram (1 day)
| Milestone | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management
| Participants | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| Number of Participants for Which DBT Altered Surgical Plan | 0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over During tomosynthesis procedure, up to 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3-dimensional Tomosynthesis Mammogram | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
Participants who went on study
| Age, Customized(Participants) | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| years — 20-29 | 1 |
| years — 30-39 | 2 |
| years — 40-49 | 4 |
| years — 50-59 | 6 |
| years — 60-69 | 3 |
| Sex: Female, Male(Participants) | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| Female | 16 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| United States | 16 |
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