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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-dimensional tomosynthesis mammogram | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-dimensional mammogram | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At completion of 3-Dimensional mammogram (1 day) |
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| Measure | Description | 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) |
Inclusion Criteria:
Exclusion Criteria:
Patient with a diagnosis of breast cancer and identifying as female
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| Name | Affiliation | Role |
|---|---|---|
| Nidhi Sharma, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who went on study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | At completion of 3-Dimensional mammogram (1 day) |
|
During tomosynthesis procedure, up to 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nidhi Sharma | Cleveland Clinic, Case Comprehensive Cancer Center | +1 216-444-9014 | sharman2@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2019 | Jun 1, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram
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|
| digital breast tomosynthesis (DBT) | Device | 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. |
|
|
| Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings | At completion of 3-Dimensional mammogram (1 day) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT | Not Posted | At completion of 3-Dimensional mammogram (1 day) | Participants |
| Other Pre-specified | The Proportion of Patients Undergoing Additional Work-up Following the DBT | Not Posted | At completion of 3-Dimensional mammogram (1 day) | Participants |
| Other Pre-specified | Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings | Not Posted | At completion of 3-Dimensional mammogram (1 day) | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D017437 |
| Skin and Connective Tissue Diseases |