Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Single-armed study. Women are their own controls with paired images of digital mammography and breast tomosynthesis.

Women in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program.

DBT and FFDM

Sophia Zackrisson, MD PhD

Ingvar Andersson, MD PhD

To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.

Mammography is the only approved method for breast cancer screening, but not all tumors can be detected with mammography. The main reason is overlapping structures that can either mimic or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis, (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A tomographic technique like DBT, which reduces or eliminates the detrimental effect of over- and underlying tissue, can probably help to find more tumors. This study aims to investigate whether more breast cancers can be detected with DBT compared to full field digital mammography (FFDM) in population invited to screening. An interim analysis will be performed during 2013 including the first 7,500 women of the study cohort.

Malmö Breast Tomosynthesis Screening Trial

Sensitivity and specificity for breast cancer detection will be assessed for DBT and DM respectively. The following screening performance measures will also also investigated: the number of detected cancers per 1000 women screened, the number of recalled women/100 screens (recall rate) after consensus, and the positive predictive value (PPV) for screen-recall and the negative predictive value (NPV), in both reading arms. Analyses of the contribution from different reading steps will be investigated. A follow-up period of 24 months after the intervention period will provide information on the actual numbers of breast cancers in the study population through record linkage with the Swedish Cancer Registry.

To investigate the biological characteristics of the cancers in the trial by mode of detection (screening detected, interval cancers)

to investigate the cost-effectiveness of DBT in screening

Unilabs AB Sweden

Region Skane

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

Subjects underwent FFDM breast imaging followed by DBT breast imaging

The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

ADAPT-ENRICH will supplement an on-going program (ADAPT) which consists of 2 additional recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography ADAPT-Enrich: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy After Screening Digital Breast Tomosynthesis Exam

Number of device-related malfunctions by imaging modality.

For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.

Lesions were characterized based on findings identified during image evaluations performed by qualified readers.

Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.

Length of Lesions (measured in mm) when images were collected using FFDM.

Length of lesions (measured in mm) when images were collected using DBT.

Describes histologic cancer and non-cancer findings of lesion biopsy.

GE Healthcare

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).

DBT and FFDM: Subjects underwent FFDM breast imaging followed by DBT breast imaging

Experimental: DBT and FFDM

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Population includes study participants who completed DBT, FFDM and lesion biopsy.

Sara Lam

Number of Participants With DBT, FFDM and Biopsy Specimens Collected

Lesion Type Observed by FFDM Imaging

Lesion Type Observed by DBT Imaging

Lesion Size as Observed by FFDM

Lesions observed and measured when images were collected using DBT

Lesion Size as Observed by DBT

All participants who completed the study.

Biopsy Finding of Lesions

Device malfunctions for FFDM

Device malfunctions for DBT

Safety - Device Related Malfunctions

Overall Study

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.

Subjects underwent breast imaging using each device: DBT and FFDM.

Corinne Balleyguier, MD

Lydia Liao, MD

Kathy Schilling, MD

The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.

ADAPT program consists of 2 recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.

All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-BX: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy

Maximum Length of Lesions (measured in mm) when images were collected using FFDM.

Maximum length of lesions (measured in mm) when images were collected using DBT

Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.

Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.

DBT and FFDM: Subjects underwent breast imaging using each device: DBT and FFDM.

Age 30 years and greater

Age, Customized

France

Participants underwent 2D breast imaging with full-field digital mammography (FFDM) and by 3D breast imaging with digital breast tomosynthesis (DBT). Digital Breast Tomosynthesis: 3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device. Full-Field Digital Mammography: 2D imaging of the breast using Full-Field Digital Mammography (FFDM) device.

Subjects also were referred (per standard of care) for a biopsy. Specimen was collected, and result was recorded.

Initially asymptomatic adult women presenting for breast biopsy based on prior breast imaging.

Number of Participants With DBT, FFDM and Biopsy Specimens Collected.

Lesion description = mass

Lesion description = calcification

Lesion description = all other

Participants with lesions evaluated by FFDM. A single participant may have more than one lesion.

Participants with DBT breast images collected, and lesion characteristic described by qualified reader. Participants may have more than one lesion.

Lesions observed and measured when images were collected when using FFDM; Seven (7) of the total 173 observed lesions were not measured.

Maximum Lesion Dimension as Observed by FFDM

Lesions observed and measured when images were collected using DBT. Sixteen (16) of the total 192 observed lesions were not measured.

Maximum Lesion Dimension as Observed by DBT

Lesions identified as "positive/malignant"

Lesions identified as "negative/benign"

Biopsy was no-conclusive

All lesions with a biopsy finding: "positive/malignant", "negative/benign" or "non-conclusive". Biopsy findings were reported per subject, not per lesion.

Biopsy Finding of Lesions Per Subject.

Number of device malfunctions recorded for either DBT or FFDM imaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Malmö Breast Tomosynthesis Screening Trial	NCT01091545	Breast Cancer	DBT and FFDM	40 Years - 74 Years	Region Skane
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography	NCT02540083	Breast Cancer Tumors, Breast	DBT and FFDM	30 Years -	GE Healthcare
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)	NCT02324205	Breast Cancer Tumors, Breast	DBT and FFDM	30 Years -	GE Healthcare
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)	NCT02324205	Breast Cancer Tumors, Breast	DBT and FFDM	30 Years -	GE Healthcare

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