Breast CancerRadioUSNCT02358837
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
An observational study of Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
With the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 236 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Jan 2015
- How long will I take part?
- 7 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The recruitment of ductosonography will target all women attending the outpatient breast clinic of the department og gynecology and Obstretic, University of Basel, Switzerland.
Who may be able to join
None listed.
Who cannot join
- a women, who have only the conventional examination of sonography
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Improving Breast Cancer Diagnostics by Novel Sonographic Techniques
With the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting and localizing breast lesions by comparing the diagnostic accuracy of ductosonography and conventional breast sonography in detecting suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of ductosonographic examination will be investigated. The second specific aim is to investigate the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS 3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of the method.
Read the detailed description
The Research Project consists of mainly two parts that involve different methodological approaches: For the first part, different breast ultrasound techniques will be employed for the examination of an unselected population in a regular setting of a breast outpatient clinic. The second part includes measuring and characterizing tissue elasticity of breast lesions by elastosonography.
- Conditions
- Breast Cancer
- Keywords
- elastosonography, comparing conventional sonography with ductosonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Sonography | Conventional Sonography to detect breast lesion | |
| Ductosonography Technique | Ductosonography Technique to detect breast lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Comparing Time of Both Procedures of Conventional Sonography Versus Ductosonography Technique Elastosonography
Measured: 3 year and 6 months
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Comparing the diagnostic accuracy of ductosonography and conventional breast sonography in the detection of breast lesions. Suspicious and unclear sonographic lesions (BI-RADS 3, 4, and 5) are clarified with a breast biopsy and malignancy confirmed by histology.
Measured: 3 year and 6 months
Secondary outcomes (1)
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Spatial precision will be evaluated by measuring the deviation in millimeters of sonographic detection sites from the site of the biopsy. Comparing the time requirement for ductosonography and traditional sonography in minutes
Measured: 3 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 236 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosanna Zanetti, PD Dr Med, Principal investigator, Claraspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358837
- Sponsor's protocol ID
- 204.08.2011
- Acronym
- RadioUS
- Status last verified
- May 2018
- First submitted
- 12 Jan 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brasier-Lutz P, Jaggi-Wickes C, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Agreement in breast lesion assessment and final BI-RADS classification between radial and meander-like breast ultrasound. BMC Med Imaging. 2021 Jun 22;21(1):104. doi: 10.1186/s12880-021-00632-1.
PubMed 34157997Jaggi-Wickes C, Brasier-Lutz P, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Comparison of radial and meander-like breast ultrasound with respect to diagnostic accuracy and examination time. Arch Gynecol Obstet. 2020 Jun;301(6):1533-1541. doi: 10.1007/s00404-020-05554-x. Epub 2020 May 3.
PubMed 32363545
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Breast Cancer Diagnostics by Novel Sonographic Techniques
- ClinicalTrials.gov ID
- NCT02358837
- Acronym / sponsor ID
- RadioUS / 204.08.2011
- Conditions
- Breast Cancer
- Keywords
- elastosonography, comparing conventional sonography with ductosonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Feb 2015 (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.
With the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting and localizing breast lesions by comparing the diagnostic accuracy of ductosonography and conventional breast sonography in detecting suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of ductosonographic examination will be investigated. The second specific aim is to investigate the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS 3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of the method.
Detailed description
The Research Project consists of mainly two parts that involve different methodological approaches: For the first part, different breast ultrasound techniques will be employed for the examination of an unselected population in a regular setting of a breast outpatient clinic. The second part includes measuring and characterizing tissue elasticity of breast lesions by elastosonography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Sonography | – | –Conventional Sonography to detect breast lesion |
| Ductosonography Technique | – | –Ductosonography Technique to detect breast lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment of ductosonography will target all women attending the outpatient breast clinic of the department og gynecology and Obstretic, University of Basel, Switzerland.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- a women, who have only the conventional examination of sonography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Time frame: 3 year and 6 months
Comparing Time of Both Procedures of Conventional Sonography Versus Ductosonography Technique Elastosonography
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Time frame: 3 year and 6 months
Comparing the diagnostic accuracy of ductosonography and conventional breast sonography in the detection of breast lesions. Suspicious and unclear sonographic lesions (BI-RADS 3, 4, and 5) are clarified with a breast biopsy and malignancy confirmed by histology.
1 secondary outcome
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Time frame: 3 year and 6 months
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 16 May 2018.
- Derived from this study: PubMed 34157997Brasier-Lutz P, Jaggi-Wickes C, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Agreement in breast lesion assessment and final BI-RADS classification between radial and meander-like breast ultrasound. BMC Med Imaging. 2021 Jun 22;21(1):104. doi: 10.1186/s12880-021-00632-1.
- Derived from this study: PubMed 32363545Jaggi-Wickes C, Brasier-Lutz P, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Comparison of radial and meander-like breast ultrasound with respect to diagnostic accuracy and examination time. Arch Gynecol Obstet. 2020 Jun;301(6):1533-1541. doi: 10.1007/s00404-020-05554-x. Epub 2020 May 3.
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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.
Rosanna Zanetti, PD Dr Med principal investigator
Claraspital Basel
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 University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 0 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: finished, as of the sponsor's last update on 16 May 2018. 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 Switzerland. 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?
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study (time frame: 3 year and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358837, which also lists 2 linked publications.
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 16 May 2018.