Breast CancerNCT01669148
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
A study testing Tomosynthesis and Conventional in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary hypothesis to be tested is: The detection of breast cancer will be increased with tomosynthesis (3D) imaging Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tomosynthesis and Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2012
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Any ethnic origin
- No contraindication for routine bilateral mammography
Who cannot join
- Potential subjects with any of the following will not be enrolled in the study:
- Any contraindications to mammographic screening, including, but not limited to:
- Significant existing breast trauma
- Under the age of 30 at the time of consent
- Breast Implants
- Prior Surgeries
Show all 9Show fewer
- Unable to understand and execute written informed consent
- Pregnant
- Lactating
Trial locations and contacts
1 site in 1 country.
About this study
The primary hypothesis to be tested is:
The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Read the detailed description
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.
- Conditions
- Breast Cancer
- Being tested
- Tomosynthesis, Conventional
- Keywords
- breast cancer, imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomosynthesisDevice
The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
ConventionalDevice
conventional (2D) imaging (standard mammography)
| Study group | Role | What they receive |
|---|---|---|
| Conventional + Tomosynthesis | Active comparator | conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later. Receives: Device: Tomosynthesis; Device: Conventional |
| Tomosynthesis alone | Active comparator | tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later. Receives: Device: Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Breast Cancer (Sensitivity)
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):
Sensitivity = TP / (TP+FN)
Measured: up to two years follow up for development of breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2011
- Study completionOct 2012
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 Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Principal investigator, Thomas J. Brady, M.D., Massachusetts General Hospital
- Investigators
- Elizabeth A Rafferty, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669148
- Sponsor's protocol ID
- 2007p-001197
- Status last verified
- Jan 2017
- First submitted
- 30 Apr 2010
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
- ClinicalTrials.gov ID
- NCT01669148
- Acronym / sponsor ID
- 2007p-001197
- Conditions
- Breast Cancer
- Keywords
- breast cancer, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Nov 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis to be tested is:
The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Detailed description
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional + Tomosynthesis | Active comparator | Device: Tomosynthesis, Device: Conventionalconventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later. |
| Tomosynthesis alone | Active comparator | Device: Tomosynthesistomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Any ethnic origin
- No contraindication for routine bilateral mammography
Key exclusion criteria (9 listed)
- Any contraindications to mammographic screening, including, but not limited to:
- Significant existing breast trauma
- Under the age of 30 at the time of consent
- Breast Implants
- Prior Surgeries
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 |
|---|---|---|
| TomosynthesisThe mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness). | Device | Conventional + Tomosynthesis, Tomosynthesis alone |
| Conventionalconventional (2D) imaging (standard mammography) | Device | Conventional + Tomosynthesis |
Primary outcome
Detection of Breast Cancer (Sensitivity)
Time frame: up to two years follow up for development of breast cancer
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Elizabeth A Rafferty, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomosynthesis and Conventional in people with Breast Cancer, run by Massachusetts General Hospital 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 3 inclusion and 9 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 14 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). 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?
Detection of Breast Cancer (Sensitivity) (time frame: up to two years follow up for development of breast cancer). 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 14 Jun 2017.