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Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Screening Tomosynthesis
Diagnostic Tomosynthesis
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Neoplasms focused on measuring breast cancer, screening, diagnostics, diagnosis, high-risk, breast neoplasms, digital mammography, mammography, tomosynthesis, dense breasts, radiation dose, comparison, Hologic, Pennsylvania, Philadelphia, breast study, mammo, tomo, mammary

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women 25 years of age or older;
  • No history of breast cancer;
  • Group A only: Asymptomatic and scheduled for screening mammography;
  • Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
  • Willing to provide a written informed consent.

Exclusion Criteria:

  • Pregnancy or intent to become pregnant;
  • Unable or unwilling to tolerate compression associated with mammography;
  • Breast implants;
  • Breasts too large to allow for adequate positioning for the DBT examination;
  • Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
  • Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
  • Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
  • Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).

Sites / Locations

  • Hospital of University of Pennsylvania
  • Albery Einstein Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: Screening

Group B: Diagnostic Enriched Population

Arm Description

Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.

Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other).

Outcomes

Primary Outcome Measures

Primary Aim: Recall Rates
To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A].

Secondary Outcome Measures

Secondary Aim: Sensitivity
To compare sensitivity of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Groups A and B].
Secondary Aim: Lesion-Type Characterization
To compare the sensitivity and specificity by lesion-type characterization (calcification-only lesions versus soft-tissue lesions, as well as lesion subgroups: masses, calcifications, architectural distortions, asymmetries) in FFDM versus DBT (two-view tomosynthesis set with low-dose MLO) [Group A call-back cohort and Group B]; To estimate the agreement of FFDM and DBT with the determination of the adjudication committee on lesion-type characterization.
Secondary Aim: Comparison of Views
To use the sequential interpretation results [Groups A and B] in order to compare the two-view limited tomosynthesis set (with low-dose MLO view alone) with the tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view) on the basis of: Call-back rate; Identification of new lesion(s); Lesion characterization; and Triangulation.
Secondary Aim: Radiation Dose
To calculate and compare the radiation dose of the FFDM and the DBT sets.
Secondary Aim: Radiation Dose and Quality
To identify the determinants of participant radiation dose and clinical image quality, including factors such as kVp, mAs, target/filter combination, and breast thickness and composition.

Full Information

First Posted
November 5, 2010
Last Updated
March 13, 2012
Sponsor
American College of Radiology Imaging Network
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01236781
Brief Title
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Official Title
Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
Pennsylvania Department of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed. Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence.
Detailed Description
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation. A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer, screening, diagnostics, diagnosis, high-risk, breast neoplasms, digital mammography, mammography, tomosynthesis, dense breasts, radiation dose, comparison, Hologic, Pennsylvania, Philadelphia, breast study, mammo, tomo, mammary

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Screening
Arm Type
Experimental
Arm Description
Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.
Arm Title
Group B: Diagnostic Enriched Population
Arm Type
Experimental
Arm Description
Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other).
Intervention Type
Device
Intervention Name(s)
Screening Tomosynthesis
Other Intervention Name(s)
Hologic, Dimension
Intervention Description
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
Intervention Type
Device
Intervention Name(s)
Diagnostic Tomosynthesis
Other Intervention Name(s)
Hologic, Dimension
Intervention Description
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
Primary Outcome Measure Information:
Title
Primary Aim: Recall Rates
Description
To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A].
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary Aim: Sensitivity
Description
To compare sensitivity of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Groups A and B].
Time Frame
1 year
Title
Secondary Aim: Lesion-Type Characterization
Description
To compare the sensitivity and specificity by lesion-type characterization (calcification-only lesions versus soft-tissue lesions, as well as lesion subgroups: masses, calcifications, architectural distortions, asymmetries) in FFDM versus DBT (two-view tomosynthesis set with low-dose MLO) [Group A call-back cohort and Group B]; To estimate the agreement of FFDM and DBT with the determination of the adjudication committee on lesion-type characterization.
Time Frame
1 year
Title
Secondary Aim: Comparison of Views
Description
To use the sequential interpretation results [Groups A and B] in order to compare the two-view limited tomosynthesis set (with low-dose MLO view alone) with the tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view) on the basis of: Call-back rate; Identification of new lesion(s); Lesion characterization; and Triangulation.
Time Frame
1 year
Title
Secondary Aim: Radiation Dose
Description
To calculate and compare the radiation dose of the FFDM and the DBT sets.
Time Frame
1 year
Title
Secondary Aim: Radiation Dose and Quality
Description
To identify the determinants of participant radiation dose and clinical image quality, including factors such as kVp, mAs, target/filter combination, and breast thickness and composition.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women 25 years of age or older; No history of breast cancer; Group A only: Asymptomatic and scheduled for screening mammography; Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed); Willing to provide a written informed consent. Exclusion Criteria: Pregnancy or intent to become pregnant; Unable or unwilling to tolerate compression associated with mammography; Breast implants; Breasts too large to allow for adequate positioning for the DBT examination; Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN; Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings; Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility; Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily F. Conant, MD
Organizational Affiliation
Hospital of University of Pennsylvania
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Albery Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.acrin.org/4006_protocol.aspx
Description
For ACRIN PA 4006 protocol-specific information, visit us online at ACRIN.ORG.

Learn more about this trial

Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

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