Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - 85 |
| Updated: | 1/6/2019 |
| Start Date: | July 1, 2017 |
| End Date: | May 2019 |
| Contact: | Nidhi Sharma, MD |
| Email: | sharman2@ccf.org |
| Phone: | 216-444-9014 |
Efficacy of Digital Breast Tomosynthesis (DBT) in Addition to Standard 2- Dimensional Mammography in Evaluating Extent of Disease in Newly Diagnosed Breast Cancer Patients
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.
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:
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).
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).
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
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Principal Investigator: Nidhi Sharma, MD
Phone: 216-444-9014
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