Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

• Sponsor: Philips Digital Mammography Sweden AB (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02615509
• Collaborator: (none)
• Enrollment: 347
• Location: 1
• Arm: 1
• Duration (Months): 25.7
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Imaging on experimental tomo device	N/A

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 347 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Feb 20, 2018
• Actual Study Completion Date: Feb 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Radiation: 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

Outcome Measures

Primary Outcome Measures

1. 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. [Up to approximately 4 weeks.]

   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.

Secondary Outcome Measures

1. Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System [Nine months image accrual]

2. Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System. [Nine months image accrual]

3. 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]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient is female and at least 40 years of age

• No contraindication for routine bilateral mammography

Screening Cohort

• Patient presents for a routine screening mammogram Biopsy Cohort

• Patient is scheduled for a biopsy

• Patient has a screening detected abnormality

Exclusion Criteria:

• Patient is pregnant or believes she may be pregnant; OR,

• Patient is breast feeding; OR

• Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR,

• Patient has breast implants; OR

• Patient has previous surgical biopsy; OR

• Patient has previous breast cancer; OR

• Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-6830

Sponsors and Collaborators

• Philips Digital Mammography Sweden AB

Investigators

• Principal Investigator: Etta Pisano, PhD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 12, 2015

More Information

Publications

None provided.

• Responsible Party: Philips Digital Mammography Sweden AB
• ClinicalTrials.gov Identifier: NCT02615509
• Other Study ID Numbers: 9RWH8K
• First Posted: Nov 26, 2015
• Last Update Posted: May 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Philips Digital Mammography Sweden AB: Mammography; Tomosynthesis

Study Results

Participant Flow

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Period Title: Overall Study
STARTED	347
COMPLETED	201
NOT COMPLETED	146

Baseline Characteristics

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Overall Participants	347
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	243 70%
>=65 years	104 30%
Sex: Female, Male (Count of Participants)
Female	347 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	347 100%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
American indian or Alaskan native	4 1.2%
Asian	5 1.4%
African American	105 30.3%
White	233 67.1%
Region of Enrollment (Count of Participants)
United States	347 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	Up to approximately 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Measure Participants	347
Biopsy proven benign	15 4.3%
Biopsy proven cancer	14 4%
Negative recalled	31 8.9%
Negative, no recall	279 80.4%
Withdrawn	8 2.3%

2. Secondary Outcome

Title	Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System
Time Frame	Nine months image accrual

Outcome Measure Data

Analysis Population Description

No data were collected due to study termination.

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Measure Participants	0

3. Secondary Outcome

Title	Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.
Time Frame	Nine months image accrual

Outcome Measure Data

Analysis Population Description

No data were collected due to study termination.

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Measure Participants	0

4. Secondary Outcome

Title	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.
Time Frame	One year follow up will be performed on negative patients

Outcome Measure Data

Analysis Population Description

No data were collected due to study termination.

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Measure Participants	0

5. Secondary Outcome

Title	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.
Time Frame	One year follow up will be performed on negative patients

Outcome Measure Data

Analysis Population Description

No data were collected due to study termination.

Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
Measure Participants	0

Adverse Events

Time Frame	1 year.
Arm/Group Title	Imaging on Experimental Tomo Device
Arm/Group Description	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
All Cause Mortality
	Imaging on Experimental Tomo Device
	Affected / at Risk (%)	# Events
Total	4/347 (1.2%)
Serious Adverse Events
	Imaging on Experimental Tomo Device
	Affected / at Risk (%)	# Events
Total	0/347 (0%)
Other (Not Including Serious) Adverse Events
	Imaging on Experimental Tomo Device
	Affected / at Risk (%)	# Events
Total	0/347 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.