Breast Cancer3DMNCT01928992
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
An observational study of Breast Cancer, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
Trial summary
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3D and 2D
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with screening and diagnostic 3D or 2D mammography
Who may be able to join
- Female subjects participating in prior FMSU protocol with known clinical status
Who cannot join
- Subjects with unkown clinical status
- Subjects not truthed in prior FMSU study
Trial locations and contacts
1 site in 1 country.
United States1 site
ACR / Image Metrix
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
- Conditions
- Breast Cancer
- Being tested
- 3D, 2D
- Keywords
- Mammography, 3D, Breast Cancer Detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DDevice
subjects that underwent 3D mammography
2DDevice
those subjects that underwent 2D mammography
| Study group | Role | What they receive |
|---|---|---|
| 3D | Subjects that undergo 3D mammography Receives: Device: 3D | |
| 2D | Subjects that undergo 2D mammography Receives: Device: 2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per Breast AUC
Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.
Measured: 1 Day
Secondary outcomes (1)
Subject Recall Rate
For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMar 2013
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl D'Orsi, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928992
- Sponsor's protocol ID
- FMSU2011-003B
- Acronym
- 3DM
- Status last verified
- Nov 2016
- First submitted
- 1 Mar 2013
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study
- ClinicalTrials.gov ID
- NCT01928992
- Acronym / sponsor ID
- 3DM / FMSU2011-003B
- Conditions
- Breast Cancer
- Keywords
- Mammography, 3D, Breast Cancer Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Aug 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.
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D | – | Device: 3DSubjects that undergo 3D mammography |
| 2D | – | Device: 2DSubjects that undergo 2D mammography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with screening and diagnostic 3D or 2D mammography
Key inclusion criteria (1 listed)
- Female subjects participating in prior FMSU protocol with known clinical status
Key exclusion criteria (2 listed)
- Subjects with unkown clinical status
- Subjects not truthed in prior FMSU study
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 |
|---|---|---|
| 3Dsubjects that underwent 3D mammography | Device | 3D |
| 2Dthose subjects that underwent 2D mammography | Device | 2D |
Primary outcome
Per Breast AUC
Time frame: 1 Day
Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.
1 secondary outcome
Subject Recall Rate
Time frame: 1 Day
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 21 Nov 2016.
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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.
Carl D'Orsi, MD principal investigator
Emory University
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 Breast Cancer, run by Fujifilm Medical Systems USA, Inc. 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 1 inclusion and 2 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 21 Nov 2016. 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?
Per Breast AUC (time frame: 1 Day). 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 21 Nov 2016.