Breast Cancer3DMNCT01542814
Collection of FUJIFILM's 3Dimensional Mammograms
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 3 sites in United States.
Trial summary
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3Dimensional Mammography and 2D FFDM
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Jun 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects who are appearing for a routine screening examination or have been referred for further diagnostic evaluation after a screening examination (within 45 days) or have a 4-view mammogram (within 45 days) due to clinical concerns will be eligible to participate in the study.
Who may be able to join
- Female.
- Any ethnic or racial origin.
- Must come through the study via the screening or diagnostic pathway described above.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Meet none of the exclusion criteria.
Who cannot join
- • Presence of a breast implant.
- Women with only a single breast; for example, post mastectomy patients.
- Is pregnant or believes she may be pregnant.
- A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
- A woman who has significant existing breast trauma.
- Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations.
Show all 10Show fewer
- A woman who has had a mammogram performed for the purpose of therapy portal planning.
- Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts.
- Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution.
- Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Healthcare
Atlanta, Georgia, 30322
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, 14620
Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, 85258
About this study
Official title: Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
Read the detailed description
This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography
- Conditions
- Breast Cancer
- Being tested
- 3Dimensional Mammography, 2D FFDM
- Keywords
- Screening Mammogram, Diagnostic Mammogram, Benign, Malignant, BI-RADS Categories
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3Dimensional MammographyDevice
Also called FUJIFILM 3Dimensional Mammography
The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.
2D FFDMDevice
Standard of care screening mammogram.
| Study group | Role | What they receive |
|---|---|---|
| Fujifilm 3Dimensional Mammography | Group of subjects being given Fujifilm 3D Mammography Imaging Receives: Device: 2D FFDM | |
| 2D FFDM | Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging Receives: Device: 3Dimensional Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquire screening cases with and without breast cancer.
Measured: 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl J. D'Orsi, MD, Principal investigator, Emory University Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542814
- Sponsor's protocol ID
- FMSU2011-003A
- Acronym
- 3DM
- Status last verified
- Oct 2013
- First submitted
- 27 Feb 2012
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
- ClinicalTrials.gov ID
- NCT01542814
- Acronym / sponsor ID
- 3DM / FMSU2011-003A
- Conditions
- Breast Cancer
- Keywords
- Screening Mammogram, Diagnostic Mammogram, Benign, Malignant, BI-RADS Categories
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Mar 2012 (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.
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
Detailed description
This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fujifilm 3Dimensional Mammography | – | Device: 2D FFDMGroup of subjects being given Fujifilm 3D Mammography Imaging |
| 2D FFDM | – | Device: 3Dimensional MammographyGroup of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who are appearing for a routine screening examination or have been referred for further diagnostic evaluation after a screening examination (within 45 days) or have a 4-view mammogram (within 45 days) due to clinical concerns will be eligible to participate in the study.
Key inclusion criteria (5 listed)
- Female.
- Any ethnic or racial origin.
- Must come through the study via the screening or diagnostic pathway described above.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Meet none of the exclusion criteria.
Key exclusion criteria (10 listed)
- • Presence of a breast implant.
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 |
|---|---|---|
| 3Dimensional MammographyAlso: FUJIFILM 3Dimensional MammographyThe FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees. | Device | 2D FFDM |
| 2D FFDMStandard of care screening mammogram. | Device | Fujifilm 3Dimensional Mammography |
Primary outcome
Acquire screening cases with and without breast cancer.
Time frame: 18-months
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 25 Oct 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Carl J. D'Orsi, MD principal investigator
Emory University Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 3 sites 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 5 inclusion and 10 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 25 Oct 2013. 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. 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?
Acquire screening cases with and without breast cancer. (time frame: 18-months). 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 25 Oct 2013.