Malignant Neoplasm, Overlapping Lesion of BreastNCT02177045
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation
A study testing Sonovue, Bracco in people with Malignant Neoplasm, Overlapping Lesion of Breast, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasm, Overlapping Lesion of Breast
- What is being tested?
- Sonovue, Bracco
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Oct 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with a diagnosed breast focal lesion
Who cannot join
- Allergic conditions to contrast media,
- asthma,
- R-L shunt
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ultrasound Unit Imaging Dept Rambam Health Care Campus
Haifa, 31096
About this study
Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.
- Being tested
- Sonovue, Bracco
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonovue, BraccoDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Microbubbles contrast media for US | Experimental | Sonovue, Bracco, microbubbles contrast media Receives: Drug: Sonovue, Bracco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor vascularization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm, Overlapping Lesion of BreastStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Gaitini, Prof, Principal investigator, Rambam Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177045
- Sponsor's protocol ID
- 0164-14-RMB CTIL
- Status last verified
- Sep 2014
- First submitted
- 26 Jun 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation
- ClinicalTrials.gov ID
- NCT02177045
- Acronym / sponsor ID
- 0164-14-RMB CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 27 Jun 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.
Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbubbles contrast media for US | Experimental | Drug: Sonovue, BraccoSonovue, Bracco, microbubbles contrast media |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female with a diagnosed breast focal lesion
Key exclusion criteria (3 listed)
- Allergic conditions to contrast media,
- asthma,
- R-L shunt
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 |
|---|---|---|
| Sonovue, BraccoIntravenous injection | Drug | Microbubbles contrast media for US |
Primary outcome
Tumor vascularization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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.
Diana Gaitini, Prof principal investigator
Rambam Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonovue, Bracco in people with Malignant Neoplasm, Overlapping Lesion of Breast, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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 1 Oct 2014. 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 Israel. 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?
Contact Diana Gainiti, Prof (972-4-7772664, d_gaitini@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor vascularization (time frame: one 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 1 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.