Breast CancerNCT00759447
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
An observational study of Breast Cancer, run by Hologic, Inc..
Trial summary
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genesis and Gemini and Investigational 3D Mammography system
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Sep 2008
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female who are undergoing screening mammography.
Who may be able to join
- Female, any ethnic origin
- No contraindication for diagnostic mammography
Who cannot join
- Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
- Under 30 years of age at the time of consent
- Unable to understand and execute written informed consent
About this study
Official title: A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Read the detailed description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
- Conditions
- Breast Cancer
- Being tested
- Genesis and Gemini, Investigational 3D Mammography system
- Keywords
- Breast cancer, tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genesis and GeminiDevice
Also called Selenia Dimensions
3 dimensional breast mammography system
Investigational 3D Mammography systemDevice
3 dimensional breast mammography system
| Study group | Role | What they receive |
|---|---|---|
| 3D investigational imaging | Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition Receives: Device: Investigational 3D Mammography system | |
| 3D Imaging with commercial Mammography Device | Not described Receives: Device: Genesis and Gemini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
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-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759447
- Sponsor's protocol ID
- 06-01
- Status last verified
- Mar 2015
- First submitted
- 24 Sep 2008
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
- ClinicalTrials.gov ID
- NCT00759447
- Acronym / sponsor ID
- 06-01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, tomosynthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Sep 2008 (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.
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Detailed description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D investigational imaging | – | Device: Investigational 3D Mammography systemPatients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition |
| 3D Imaging with commercial Mammography Device | – | Device: Genesis and Gemini |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female who are undergoing screening mammography.
Key inclusion criteria (2 listed)
- Female, any ethnic origin
- No contraindication for diagnostic mammography
Key exclusion criteria (3 listed)
- Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
- Under 30 years of age at the time of consent
- Unable to understand and execute written informed consent
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 |
|---|---|---|
| Genesis and GeminiAlso: Selenia Dimensions3 dimensional breast mammography system | Device | 3D Imaging with commercial Mammography Device |
| Investigational 3D Mammography system3 dimensional breast mammography system | Device | 3D investigational imaging |
Primary outcome
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
Time frame: 1 year
images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest
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 22 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hologic, Inc..
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 2 inclusion and 3 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design (time frame: 1 year). 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 22 Feb 2019.