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

Breast Neoplasms Clinical Trial

Official title:

Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01236781
• Other study ID #: ACRIN PA 4006
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 5, 2010
• Last updated: March 13, 2012
• Start date: December 2010

Study information

• Verified date: March 2012
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• Screening Tomosynthesis
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
• Diagnostic Tomosynthesis
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Locations

Country	Name	City	State
United States	Albery Einstein Medical Center	Philadelphia	Pennsylvania
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	1 year	No
Secondary	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].	1 year	No
Secondary	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.	1 year	No
Secondary	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.	1 year	No
Secondary	Secondary Aim: Radiation Dose	To calculate and compare the radiation dose of the FFDM and the DBT sets.	1 year	Yes
Secondary	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.	1 year	Yes

External Links

•   For ACRIN PA 4006 protocol-specific information, visit us online at ACRIN.ORG.