Image CorrectionNCT01885143
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
An observational study of Image Correction, run by GE Healthcare at 1 site in United States.
Trial summary
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Image Correction
- What is being tested?
- Digital Breast Tomosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the site's population of women recalled for further workup due to abnormalities found on screening Full-field digital Mammography exam.
Who may be able to join
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Female subjects who are 40 years of age or older
- Subject has no history of symptoms and/or physical signs of breast cancer on the side of the targeted breast
- Subject underwent routine Full-Field Digital Mammography (FFDM) which showed one or more abnormalities, including calcifications, and was referred for diagnostic work-up within 4 weeks
- Subject is surgically sterile (must have documentation of bilateral oophorectomy and/or documented hysterectomy), post-menopausal (must have documentation of cessation of menses for greater than one year) or, if of childbearing potential, a documented negative urine pregnancy test within 4 weeks is required.
- Subject breast size is compatible with the dimensions of 24x31 cm of the image detector
- Subject must be in sufficient good health to be able to undergo an examination on mammography equipment as determined by the Investigator
Who cannot join
- Subject or a legally authorized representative is unable to provide written informed consent
- Clinical assessment and DBT cannot be performed within 4 weeks of screening FFDM examination
- Subject is breast-feeding
- Subject has breast implants or reconstructed breasts
- Subject is undergoing radiotherapy or chemotherapy
- Subject has a history of prior radiotherapy treatment on the side of the targeted breast
- Subject has been previously enrolled in this study
- Subject is participating or has participated in another trial of an investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.
- Conditions
- Image Correction
- Being tested
- Digital Breast Tomosynthesis
- Keywords
- Mammography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast TomosynthesisRadiation
Also called DBT
| Study group | Role | What they receive |
|---|---|---|
| Artifact Correction | A minimum of 6 subjects will be recruited for the purpose of evaluating artifact correction Receives: Radiation: Digital Breast Tomosynthesis | |
| Lossy Compression | A minimum of 6 subjects will be recruited for the purpose of evaluating lossy compression Receives: Radiation: Digital Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
DBT in Senographe Essential is of acceptable quality according to FDA criteria
Collect 12 clinical DBT cases with MLO and CC views taken from the Senographe Essential to assess whether the DBT in Senographe Essential is of acceptable quality according to FDA criteria following the clinical evaluation instructions described in Section 9 of the guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System". Assessment will include review of images with and without artifact correction and with and without lossy compression and findings will be included in PMA submission.
Measured: Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image CorrectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murray Rebner, MD, Principal investigator, Beaumont Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885143
- Sponsor's protocol ID
- 101.01-2013-GES-0001
- Status last verified
- Dec 2014
- First submitted
- 14 Jun 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
- ClinicalTrials.gov ID
- NCT01885143
- Acronym / sponsor ID
- 101.01-2013-GES-0001
- Conditions
- Image Correction
- Keywords
- Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artifact Correction | – | Radiation: Digital Breast TomosynthesisA minimum of 6 subjects will be recruited for the purpose of evaluating artifact correction |
| Lossy Compression | – | Radiation: Digital Breast TomosynthesisA minimum of 6 subjects will be recruited for the purpose of evaluating lossy compression |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the site's population of women recalled for further workup due to abnormalities found on screening Full-field digital Mammography exam.
Key inclusion criteria (7 listed)
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Female subjects who are 40 years of age or older
- Subject has no history of symptoms and/or physical signs of breast cancer on the side of the targeted breast
- Subject underwent routine Full-Field Digital Mammography (FFDM) which showed one or more abnormalities, including calcifications, and was referred for diagnostic work-up within 4 weeks
- Subject is surgically sterile (must have documentation of bilateral oophorectomy and/or documented hysterectomy), post-menopausal (must have documentation of cessation of menses for greater than one year) or, if of childbearing potential, a documented negative urine pregnancy test within 4 weeks is required.
Key exclusion criteria (8 listed)
- Subject or a legally authorized representative is unable to provide written informed consent
- Clinical assessment and DBT cannot be performed within 4 weeks of screening FFDM examination
- Subject is breast-feeding
- Subject has breast implants or reconstructed breasts
- Subject is undergoing radiotherapy or chemotherapy
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 |
|---|---|---|
| Digital Breast TomosynthesisAlso: DBT | Radiation | Artifact Correction, Lossy Compression |
Primary outcome
DBT in Senographe Essential is of acceptable quality according to FDA criteria
Time frame: Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 weeks
Collect 12 clinical DBT cases with MLO and CC views taken from the Senographe Essential to assess whether the DBT in Senographe Essential is of acceptable quality according to FDA criteria following the clinical evaluation instructions described in Section 9 of the guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System". Assessment will include review of images with and without artifact correction and with and without lossy compression and findings will be included in PMA submission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Murray Rebner, MD principal investigator
Beaumont Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Image Correction, run by GE Healthcare at 1 site in United States.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DBT in Senographe Essential is of acceptable quality according to FDA criteria (time frame: Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 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 2 Dec 2014.