Breast CancerADAPTNCT02324205
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
A study testing DBT and FFDM in people with Breast Cancer and Tumors, Breast, run by GE Healthcare at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer, Tumors, Breast
- What is being tested?
- DBT and FFDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to 29 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute
Boca Raton, Florida, 33486
Cooper Health - Cooper Breast Imaging Centers
Voorhees Township, New Jersey, 08043
About this study
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
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Tumors, Breast
- Being tested
- DBT and FFDM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT and FFDMDevice
Also called Digital Breast Tomosynthesis (3D breast imaging) and Full-Field Digital Mammography (2D breast imaging), 3D breast imaging and 2D breast imaging
Subjects underwent breast imaging using each device: DBT and FFDM.
| Study group | Role | What they receive |
|---|---|---|
| DBT and FFDM | Experimental | 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. Receives: Device: DBT and FFDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 8 weeks
Secondary outcomes (5)
Lesion Type Observed by FFDM Imaging
Lesions were characterized based on findings identified during image evaluations performed by qualified readers.
Measured: Approximately 8 weeks
Lesion Type Observed by DBT Imaging
Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.
Measured: Approximately 8 weeks
Maximum Lesion Dimension as Observed by FFDM
Maximum Length of Lesions (measured in mm) when images were collected using FFDM.
Measured: Approximately 8 weeks
Maximum Lesion Dimension as Observed by DBT
Maximum length of lesions (measured in mm) when images were collected using DBT
Measured: Approximately 8 weeks
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.
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMar 2015
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Why it stopped: Sponsor met enroll. need for planned second study before meeting enroll. ceiling in protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corinne Balleyguier, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisLydia Liao, MD, Principal investigator, Cooper HealthKathy Schilling, MD, Principal investigator, Boca Raton Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324205
- Sponsor's protocol ID
- 124.03-2014-GES-0010_2
- Acronym
- ADAPT
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2014
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02324205
- Acronym / sponsor ID
- ADAPT / 124.03-2014-GES-0010_2
- Conditions
- Breast Cancer, Tumors, Breast
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor met enroll. need for planned second study before meeting enroll. ceiling in protocol
- Enrolment
- 196 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants underwent 2D breast imaging with Full-field digital mammography (FFDM) and by 3D breast imaging with Digital Breast Tomosynthesis (DBT).
| Arm | Type | Receives |
|---|---|---|
| DBT and FFDM | Experimental | Device: DBT and FFDMSubjects 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT and FFDMAlso: Digital Breast Tomosynthesis (3D breast imaging) and Full-Field Digital Mammography (2D breast imaging), 3D breast imaging and 2D breast imagingSubjects underwent breast imaging using each device: DBT and FFDM. | Device | DBT and FFDM |
Primary outcome
Number of Participants With DBT, FFDM and Biopsy Specimens Collected.
Time frame: Approximately 8 weeks
For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.
5 secondary outcomes
Lesion Type Observed by FFDM Imaging
Time frame: Approximately 8 weeks
Lesion Type Observed by DBT Imaging
Time frame: Approximately 8 weeks
Maximum Lesion Dimension as Observed by FFDM
Time frame: Approximately 8 weeks
Maximum Lesion Dimension as Observed by DBT
Time frame: Approximately 8 weeks
Biopsy Finding of Lesions Per Subject.
Time frame: Approximately 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Balleyguier, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Lydia Liao, MD principal investigator
Cooper Health
Kathy Schilling, MD principal investigator
Boca Raton Regional Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT and FFDM in people with Breast Cancer and Tumors, Breast, run by GE Healthcare at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With DBT, FFDM and Biopsy Specimens Collected. (time frame: Approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.