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Discontinuation of development of device.
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The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.
The study will be performed in two phases: Image Accrual and Image Reading.
Approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different US sites with one study investigator for each site. Two cohorts of patients will be enrolled (i.e., Biopsy and Screening Cohorts). Paired sets of a standard 4-view exam will be collected both from Philips Tomosynthesis system (Tomosynthesis and synthetic 2D images) and a FDA-cleared FFDM system. All enrolled cases will be quality controlled for completeness of image and patient information.
The reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases.
The primary objective of the study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system (Tomosynthesis and synthetic 2D) images to conventional 2D mammography images (FFDM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging on experimental tomo device | Other | Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised. After collecting the cases together with ground truth a readers study will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging on experimental tomo device | Radiation | The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve. | Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors. | Up to approximately 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System | Nine months image accrual | |
| Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System. | Nine months image accrual |
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Inclusion Criteria:
Screening Cohort
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etta Pisano, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-6830 | United States |
No individual participant data will be shared with researchers outside the company or otherwise engaged in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imaging on Experimental Tomo Device | Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised. After collecting the cases together with ground truth a readers study will be performed. Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imaging on Experimental Tomo Device | Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised. After collecting the cases together with ground truth a readers study will be performed. Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve. | Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors. | Posted | Count of Participants | Participants | Up to approximately 4 weeks. |
|
1 year.
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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 | Imaging on Experimental Tomo Device | Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised. After collecting the cases together with ground truth a readers study will be performed. Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Stenströmer | Philips AB | +46 708 303 767 | daniel.stenstromer@philips.com |
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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 | Aug 12, 2015 | Apr 23, 2020 | Prot_SAP_000.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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| Compare Sensitivity Between FDDM and Philips Tomosynthesis System, Sensitivity Will be Estimated for Each Reader as the Proportion of Cancer Cases With Per-case BI-RADS Category 4 or Higher. | One year follow up will be performed on negative patients |
| Compare Specificity Between FDDM and Philips Tomosynthesis System. Specificity Will be Estimated by Reader as the Proportion of Non-cancer Cases With Per-case BI-RADS Category Less Than 4. | One year follow up will be performed on negative patients |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
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| Secondary | Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System | No data were collected due to study termination. | Posted | Nine months image accrual |
|
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| Secondary | Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System. | No data were collected due to study termination. | Posted | Nine months image accrual |
|
|
| Secondary | Compare Sensitivity Between FDDM and Philips Tomosynthesis System, Sensitivity Will be Estimated for Each Reader as the Proportion of Cancer Cases With Per-case BI-RADS Category 4 or Higher. | No data were collected due to study termination. | Posted | One year follow up will be performed on negative patients |
|
|
| Secondary | Compare Specificity Between FDDM and Philips Tomosynthesis System. Specificity Will be Estimated by Reader as the Proportion of Non-cancer Cases With Per-case BI-RADS Category Less Than 4. | No data were collected due to study termination. | Posted | One year follow up will be performed on negative patients |
|
|
| 4 |
| 347 |
| 0 |
| 347 |
| 0 |
| 347 |
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| D017437 |
| Skin and Connective Tissue Diseases |