Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

NCT ID: NCT02358837

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional Sonography

Conventional Sonography to detect breast lesion

No interventions assigned to this group

Ductosonography Technique

Ductosonography Technique to detect breast lesion

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

a women, who have only the conventional examination of sonography
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosanna Zanetti, PD Dr Med

Role: PRINCIPAL_INVESTIGATOR

Claraspital Basel

Locations

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University Hospital of Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34157997 (View on PubMed)

Jaggi-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.

Reference Type DERIVED
PMID: 32363545 (View on PubMed)

Other Identifiers

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204.08.2011

Identifier Type: -

Identifier Source: org_study_id

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