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

Breast Cancer Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324205
• Other study ID #: 124.03-2014-GES-0010_2
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 29, 2017

Study information

• Verified date: February 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 196
• Est. completion date: August 29, 2017
• Est. primary completion date: August 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Women aged 30 years or older (=30 years old);

• Initially asymptomatic women that underwent routine screening FFDM, breast ultrasound (U/S), breast magnetic resonance imaging (MRI) and/or DBT, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry;

• Are able and willing to comply with study procedures;

• Have signed and dated the informed consent form;

• Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy.

Exclusion Criteria:

• Have been previously included in this study;

• Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging;

• Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during a DBT examination (or FFDM, if required);

• Have participated in (within the prior 30 days), another trial of an investigational product expected to interfere with study procedures or outcomes;

• Have breast implant(s);

• Have reconstructed breast(s).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Tumors, Breast

Intervention

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

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif
United States	Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute	Boca Raton	Florida
United States	Cooper Health - Cooper Breast Imaging Centers	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety - Device Related Malfunctions	Number of device-related malfunctions by imaging modality.	less than 16 months
Primary	Number of Participants With DBT, FFDM and Biopsy Specimens Collected.	For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.	Approximately 8 weeks
Secondary	Lesion Type Observed by FFDM Imaging	Lesions were characterized based on findings identified during image evaluations performed by qualified readers.	Approximately 8 weeks
Secondary	Lesion Type Observed by DBT Imaging	Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.	Approximately 8 weeks
Secondary	Maximum Lesion Dimension as Observed by FFDM	Maximum Length of Lesions (measured in mm) when images were collected using FFDM.	Approximately 8 weeks
Secondary	Maximum Lesion Dimension as Observed by DBT	Maximum length of lesions (measured in mm) when images were collected using DBT	Approximately 8 weeks
Secondary	Biopsy Finding of Lesions Per Subject.	Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.	Approximately 8 weeks