Breast CancerLIP2SIPNCT00756496
Case Collection Study to Support Digital Mammography Image Software Change
A study testing Mammography screening and diagnosis in people with Breast Cancer, run by Siemens Medical Solutions USA - CSG.
Trial summary
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system. 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?
- Mammography screening and diagnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2009
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- > 40 years
Who cannot join
- Pregnant women, or women who may become pregnant
- Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
- Palpable lesion or one that is visible by another modality
- Inmates
About this study
Official title: A Multi-center Feature Analysis Study to Compare the Diagnostic Accuracy of Siemens' Image Processing (SIP) Algorithms With Lorad's Image Processing (LIP) Algorithms in Detecting and Characterizing Breast Lesions
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Conditions
- Breast Cancer
- Being tested
- Mammography screening and diagnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography screening and diagnosisDevice
Mammography screening and diagnosis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Mammography screening and diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis
The primary objective of this study was to demonstrate non-inferiority of the Siemens' processing algorithm to Lorad's processing algorithm with regards to readers' diagnostic accuracy in detecting and characterizing breast lesions. The non-inferiority analyses were performed by comparing the area under the ROC curve (AUC) for the two algorithms \& to compare false positive marks per subject.
The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. It shows in a graphical way the trade-off between clinical sensitivity and specificity for every possible cut-off for a test, and gives an idea about the benefit of using the test in question. The higher the total area under the curve, the greater the predictive power of the reader assessments.
A breast-based analysis was used for the primary AUC comparison in order to obtain additional power by having more normal/benign breasts.
Measured: ~1 year. Women with negative or biopsy benign findings at baseline (study entry) were followed for 1 year to confirm the negative status at 1-year follow-up mammography exam. Women diagnosed with cancer were not followed up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionJan 2009
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.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Medical Solutions USA - CSG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond C Duhamel, Ph.D., Study director, Siemens Medical Solutions USA, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756496
- Sponsor's protocol ID
- SMS-SP04-06
- Acronym
- LIP2SIP
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2008
- Last updated
- 7 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Feature Analysis Study to Compare the Diagnostic Accuracy of Siemens' Image Processing (SIP) Algorithms With Lorad's Image Processing (LIP) Algorithms in Detecting and Characterizing Breast Lesions
- ClinicalTrials.gov ID
- NCT00756496
- Acronym / sponsor ID
- LIP2SIP / SMS-SP04-06
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Siemens Medical Solutions USA - CSGIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Mammography screening and diagnosis |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- > 40 years
Key exclusion criteria (4 listed)
- Pregnant women, or women who may become pregnant
- Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
- Palpable lesion or one that is visible by another modality
- Inmates
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 |
|---|---|---|
| Mammography screening and diagnosisMammography screening and diagnosis | Device | 1 |
Primary outcome
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis
Time frame: ~1 year. Women with negative or biopsy benign findings at baseline (study entry) were followed for 1 year to confirm the negative status at 1-year follow-up mammography exam. Women diagnosed with cancer were not followed up.
The primary objective of this study was to demonstrate non-inferiority of the Siemens' processing algorithm to Lorad's processing algorithm with regards to readers' diagnostic accuracy in detecting and characterizing breast lesions. The non-inferiority analyses were performed by comparing the area under the ROC curve (AUC) for the two algorithms \& to compare false positive marks per subject. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. It shows in a graphical way the trade-off between clinical sensitivity and specificity for every possible cut-off for a test, and gives an idea about the benefit of using the test in question. The higher the total area under the curve, the greater the predictive power of the reader assessments. A breast-based analysis was used for the primary AUC comparison in order to obtain additional power by having more normal/benign breasts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- 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.
Raymond C Duhamel, Ph.D. study director
Siemens Medical Solutions USA, Inc
Questions about this trial
What is this clinical trial studying?
A study testing Mammography screening and diagnosis in people with Breast Cancer, run by Siemens Medical Solutions USA - CSG.
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 4 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 7 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2020). 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?
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis (time frame: ~1 year. Women with negative or biopsy benign findings at baseline (study entry) were followed for 1 year to confirm the negative status at 1-year follow-up mammography exam. Women diagnosed with cancer were not followed up.). 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 7 Dec 2020.