Breast CancerNCT02096185
Is Any Additional Information Gained Regarding Margins Using 3D Tomosynthesis Vs 2D Conventional Digital Imaging When Imaging Operative Breast Specimens?
A study testing 3 dimensional tomosynthesis imaging and 2 dimensional digital imaging in people with Breast Cancer, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to assess that the abnormality has been removed and give an estimation of the distance from lesion to specimen edge. 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?
- 3 dimensional tomosynthesis imaging and 2 dimensional digital imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patient requires surgery to remove breast cancer and operative specimen needs to be x-rayed
Who cannot join
- Patients with breast cancer who need mastectomy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, West Midlands, B18 7QH
About this study
Official title: Is Any Additional Information Gained Regarding Lesion to Margin Measurement Using 3D Tomosynthesis Imaging Versus 2D Conventional Digital Imaging When Imaging Specimens of Breast Tissue Removed at Therapeutic Surgery
Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to assess that the abnormality has been removed and give an estimation of the distance from lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or not at the time. This study is designed to compare whether more accurate information about lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging compared to 2 dimensional conventional digital imaging which is the type of imaging currently used. This has the potential to prevent some patients requiring a second operation to remove more tissue if the margins of the specimen are still involved with tumour.
The study involves x-raying the specimen under both conditions when it arrives from theatre. Only the 2D image will be reviewed at the time as is current practice. The 3D image will be reviewed later and the measurements for lesion to specimen margin compared. The lesion to margin measurement as recorded by the pathologist will be taken as the 'gold standard' and the imaging measurements will also be compared to that.
Read more
In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin measurement because 3D can provide better visualisation of the lesion edges by removing the effect of superimposed tissue.
The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide better lesion visualisation compared to 2 dimensional conventional digital imaging thus allowing more accurate lesion to margin measurement.
- Conditions
- Breast Cancer
- Being tested
- 3 dimensional tomosynthesis imaging, 2 dimensional digital imaging
- Keywords
- Breast cancer, Surgery, Specimen 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.
3 dimensional tomosynthesis imagingRadiation
Each operative specimen will be imaged twice using each condition
2 dimensional digital imagingRadiation
| Study group | Role | What they receive |
|---|---|---|
| 3 dimensional tomosynthesis imaging | Experimental | Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging Receives: Radiation: 3 dimensional tomosynthesis imaging |
| 2 dimensional digital imaging | Experimental | Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging Receives: Radiation: 2 dimensional digital imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shortest distance in mm from visible lesion to specimen margin
2D conventional digital imaging - measured at time of surgery and info relayed to surgeon in theatre 3D tomosynthesis imaging - measured later with operator blinded to the 2D measurement Pathological measurement - final measurement used as the 'gold standard'
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 posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Waldron, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Jennifer Waldron, Principal investigator, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096185
- Sponsor's protocol ID
- Breast Specimen Imaging Ver3
- Status last verified
- Nov 2015
- First submitted
- 21 Mar 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Any Additional Information Gained Regarding Lesion to Margin Measurement Using 3D Tomosynthesis Imaging Versus 2D Conventional Digital Imaging When Imaging Specimens of Breast Tissue Removed at Therapeutic Surgery
- ClinicalTrials.gov ID
- NCT02096185
- Acronym / sponsor ID
- Breast Specimen Imaging Ver3
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Surgery, Specimen imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 26 Mar 2014 (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.
Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to assess that the abnormality has been removed and give an estimation of the distance from lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or not at the time. This study is designed to compare whether more accurate information about lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging compared to 2 dimensional conventional digital imaging which is the type of imaging currently used. This has the potential to prevent some patients requiring a second operation to remove more tissue if the margins of the specimen are still involved with tumour.
The study involves x-raying the specimen under both conditions when it arrives from theatre. Only the 2D image will be reviewed at the time as is current practice. The 3D image will be reviewed later and the measurements for lesion to specimen margin compared. The lesion to margin measurement as recorded by the pathologist will be taken as the 'gold standard' and the imaging measurements will also be compared to that.
In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin measurement because 3D can provide better visualisation of the lesion edges by removing the effect of superimposed tissue.
The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide better lesion visualisation compared to 2 dimensional conventional digital imaging thus allowing more accurate lesion to margin measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 dimensional tomosynthesis imaging | Experimental | Radiation: 3 dimensional tomosynthesis imagingBreast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging |
| 2 dimensional digital imaging | Experimental | Radiation: 2 dimensional digital imagingBreast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient requires surgery to remove breast cancer and operative specimen needs to be x-rayed
Key exclusion criteria (1 listed)
- Patients with breast cancer who need mastectomy
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 |
|---|---|---|
| 3 dimensional tomosynthesis imagingEach operative specimen will be imaged twice using each condition | Radiation | 3 dimensional tomosynthesis imaging |
| 2 dimensional digital imaging | Radiation | 2 dimensional digital imaging |
Primary outcome
Shortest distance in mm from visible lesion to specimen margin
Time frame: 1 year
2D conventional digital imaging - measured at time of surgery and info relayed to surgeon in theatre 3D tomosynthesis imaging - measured later with operator blinded to the 2D measurement Pathological measurement - final measurement used as the 'gold standard'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.
Jennifer Waldron principal investigator
Sandwell & West Birmingham Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dimensional tomosynthesis imaging and 2 dimensional digital imaging in people with Breast Cancer, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 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 Kingdom. 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?
Results are not available in the source record.
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?
Shortest distance in mm from visible lesion to specimen margin (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 21 Oct 2016.