Breast Cancer
Conditions
Keywords
mastectomy, lumpectomy, 3-Dimensional Mammogram, digital breast tomosynthesis
Brief summary
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.
Detailed description
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: 1. To measure the frequency and nature of additional findings like atypical pathology (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) , requiring surgical intervention). 2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from DBT. 3. To measure the proportion of patients undergoing additional work-up following the DBT, and the subset of these patients with benign findings (i.e. False Positives).
Interventions
DEVICE2-dimensional mammogram
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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* New diagnosis of breast cancer * New diagnosis if a previous breast cancer patient with negative surgical margins * Patients willing to sign a written informed consent form
Exclusion criteria
* High risk benign lesions as the primary pathology diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Which DBT Altered Surgical Plan | At completion of 3-Dimensional mammogram (1 day) | 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 |
Other
| Measure | Time frame |
|---|---|
| Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT | At completion of 3-Dimensional mammogram (1 day) |
| The Proportion of Patients Undergoing Additional Work-up Following the DBT | At completion of 3-Dimensional mammogram (1 day) |
| Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings | At completion of 3-Dimensional mammogram (1 day) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3-dimensional Tomosynthesis Mammogram 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
2-dimensional mammogram: 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.
digital breast tomosynthesis (DBT): 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | 3-dimensional Tomosynthesis Mammogram |
|---|---|
| Age, Customized years 20-29 | 1 Participants |
| Age, Customized years 30-39 | 2 Participants |
| Age, Customized years 40-49 | 4 Participants |
| Age, Customized years 50-59 | 6 Participants |
| Age, Customized years 60-69 | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3-dimensional Tomosynthesis Mammogram | Number of Participants for Which DBT Altered Surgical Plan | 0 Participants |
Other Pre-specified
Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings
Time frame: At completion of 3-Dimensional mammogram (1 day)
Other Pre-specified
The Proportion of Patients Undergoing Additional Work-up Following the DBT
Time frame: At completion of 3-Dimensional mammogram (1 day)
Other Pre-specified
Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT
Time frame: At completion of 3-Dimensional mammogram (1 day)