Breast CancerNCT03276845
Multiparametric High-resolution Ultrasound of the Breast
A study testing Ultrasound of the breast in people with Breast Cancer, run by Medical University of Vienna.
Trial summary
Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound of the breast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a suspicious breast lesion (BIRADS 4 and 5)
- Age > 18 years
- Written informed consent
- Histopathological verification of the lesions either by core biopsy or by surgical excision
Who cannot join
- Unstable or non-compliant patients
- Pregnant or lactating patients or patients with suspected pregnancy
- Known contraindication to the intravenous administration of US contrast agents
- Acute or chronic renal insufficiency
- Pre- or post-transplant patients
About this study
Official title: Multiparametric High-resolution 3-D Sonography With Color/Power-Doppler, Elastography and Contrast-enhanced Sonography for an Improved Detection and Characterization of Breast Tumors
Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts.
However, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. On the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. On the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult.
Read more
To overcome these limitations, newer sonographic methods have been developed. These include elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.
The application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma.
In addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power Doppler. The detection of neoangiogenesis can be improved by the application of contrast agents. The latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics.
Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated.
The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power Doppler, contrast agent application and 3D sonography. Both morphological and functional information can thus be obtained. The primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound of the breast
- Keywords
- Ultrasound, Elastography, Doppler Ultrasound, Contrast enhanced Ultrasound, Three-dimensional Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the breastDiagnostic test
Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Diagnostic Test: Ultrasound of the breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)
H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.
H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study startSep 2015
- Primary completionApr 2017
- Study completionSep 2017
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.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Kapetas, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276845
- Sponsor's protocol ID
- Multiparametric breast US
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric High-resolution 3-D Sonography With Color/Power-Doppler, Elastography and Contrast-enhanced Sonography for an Improved Detection and Characterization of Breast Tumors
- ClinicalTrials.gov ID
- NCT03276845
- Acronym / sponsor ID
- Multiparametric breast US
- Conditions
- Breast Cancer
- Keywords
- Ultrasound, Elastography, Doppler Ultrasound, Contrast enhanced Ultrasound, Three-dimensional Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts.
However, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. On the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. On the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult.
To overcome these limitations, newer sonographic methods have been developed. These include elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.
The application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma.
In addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power Doppler. The detection of neoangiogenesis can be improved by the application of contrast agents. The latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics.
Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated.
The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power Doppler, contrast agent application and 3D sonography. Both morphological and functional information can thus be obtained. The primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Diagnostic Test: Ultrasound of the breast |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a suspicious breast lesion (BIRADS 4 and 5)
- Age > 18 years
- Written informed consent
- Histopathological verification of the lesions either by core biopsy or by surgical excision
Key exclusion criteria (5 listed)
- Unstable or non-compliant patients
- Pregnant or lactating patients or patients with suspected pregnancy
- Known contraindication to the intravenous administration of US contrast agents
- Acute or chronic renal insufficiency
- Pre- or post-transplant patients
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 |
|---|---|---|
| Ultrasound of the breastMultiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography. | Diagnostic test | 1 |
Primary outcome
Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve)
Time frame: 2 years
H0: There is no difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques. H1: There is a difference in diagnostic accuracy of breast ultrasound through the addition of further sonographic techniques.
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 8 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the breast in people with Breast Cancer, run by Medical University of Vienna.
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 4 inclusion and 5 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 8 Sep 2017. 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?
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?
Diagnostic accuracy (sensitivity, specificity, area under the receiver operating characteristic-ROC curve) (time frame: 2 years). 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 8 Sep 2017.