Breast CancerNCT00355745
Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis
A study testing Ultrasound breast scanning in people with Breast Cancer, run by Helix Medical Systems at 1 site in Israel.
Trial summary
In the United States, breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second most common cause of death from cancer in women (after lung cancer). Approximately 182,800 new cases per year occur in the United States, causing 40,800 death cases per year. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound breast scanning
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to Jul 2009
- 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 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female age between 21-70 years.
- Subject has mammography or ultrasound findings
- Subject is scheduled for biopsy.
- Subject is scheduled for ultrasound breast scan.
- Subject understands the study procedure.
- Subject is willing to sign the inform consent and comply with the study requirements.
Who cannot join
- Age < 21 years or > 70 years.
- Subject undergo previous breast surgery
- Known blood coagulation disorders.
- Known cardiac disorders.
- Breast infection / breast abscess / breast pains.
- Ipsilateral breast scar in same quadrant as current lesion
Show all 14Show fewer
- Recent breast trauma.
- Pregnant or lactating woman
- Subject has bleeding disorder.
- Subject is suffering extreme general weakness.
- Subject objects to the study protocol.
- Physician objection.
- Known cognitive or psychiatric disorder
- Participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
In the United States, breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second most common cause of death from cancer in women (after lung cancer). Approximately 182,800 new cases per year occur in the United States, causing 40,800 death cases per year. Breast cancer is the leading cause of death in women aged 44-50 years. The 5-year survival rate is 60% overall but is greater than 80% for early disease.
If diagnosed at an early stage, breast cancer has an encouraging cure rate: up to 97% of women diagnosed with localized breast cancer will survive five years after their diagnosis. Even if the cancer is found at a more advanced stage, new therapies have enabled many people with breast cancer to experience the same quality of life as before their diagnosis.
Read more
Breast ultrasound (US) is an extremely useful modality in the diagnosis of breast disease in the symptomatic clinic. It is routinely used as an adjunct to x-ray mammography and clinical examination and, with younger patients it may be the sole imaging modality. It has well-established value in differentiating between malignant and benign solid lesions in some cases, however, it cannot replace fine needle aspiration and core biopsy.
Conventional breast US scanning is highly operator- dependent, requiring skillful probe manipulation and the mental ability to envisage 3-D tissue structure. Acquiring 3-D US data sets may be advantageous, making it easier to see and interpret 3-D structures, boundaries and interactions.
CBUS™, Circular Breast Ultrasound Scanner is indicated to improve significantly breast images obtained by ultrasound systems. The CBUS™ system automatically acquires a complete breast image and constructs a high quality 3D image of the scanned breast. These images provide diagnostic information of the complete volume of breast tissue including blood flow in a single ultrasonic 3D image.
In this clinical study, the CBUS™ Circular Breast Ultrasound Scanner will be used to automatically image the complete breast and provides a high quality 3D image of the scanned breast.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound breast scanning
- Keywords
- Breast, tumor, ultrasound, biopsy, Breast mammographic or ultrasound findings
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound breast scanningDevice
breast scanning
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of adverse events
Measured: immediately
Secondary outcomes (1)
Quality of ultrasound imaging
Measured: within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionJul 2009
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helix Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanna Levy, PhD, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355745
- Sponsor's protocol ID
- CBUS -RA-001
- Status last verified
- May 2008
- First submitted
- 22 Jul 2006
- Last updated
- 9 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis
- ClinicalTrials.gov ID
- NCT00355745
- Acronym / sponsor ID
- CBUS -RA-001
- Conditions
- Breast Cancer
- Keywords
- Breast, tumor, ultrasound, biopsy, Breast mammographic or ultrasound findings
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helix Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jul 2006 (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.
In the United States, breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second most common cause of death from cancer in women (after lung cancer). Approximately 182,800 new cases per year occur in the United States, causing 40,800 death cases per year. Breast cancer is the leading cause of death in women aged 44-50 years. The 5-year survival rate is 60% overall but is greater than 80% for early disease.
If diagnosed at an early stage, breast cancer has an encouraging cure rate: up to 97% of women diagnosed with localized breast cancer will survive five years after their diagnosis. Even if the cancer is found at a more advanced stage, new therapies have enabled many people with breast cancer to experience the same quality of life as before their diagnosis.
Breast ultrasound (US) is an extremely useful modality in the diagnosis of breast disease in the symptomatic clinic. It is routinely used as an adjunct to x-ray mammography and clinical examination and, with younger patients it may be the sole imaging modality. It has well-established value in differentiating between malignant and benign solid lesions in some cases, however, it cannot replace fine needle aspiration and core biopsy.
Conventional breast US scanning is highly operator- dependent, requiring skillful probe manipulation and the mental ability to envisage 3-D tissue structure. Acquiring 3-D US data sets may be advantageous, making it easier to see and interpret 3-D structures, boundaries and interactions.
CBUS™, Circular Breast Ultrasound Scanner is indicated to improve significantly breast images obtained by ultrasound systems. The CBUS™ system automatically acquires a complete breast image and constructs a high quality 3D image of the scanned breast. These images provide diagnostic information of the complete volume of breast tissue including blood flow in a single ultrasonic 3D image.
In this clinical study, the CBUS™ Circular Breast Ultrasound Scanner will be used to automatically image the complete breast and provides a high quality 3D image of the scanned breast.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female age between 21-70 years.
- Subject has mammography or ultrasound findings
- Subject is scheduled for biopsy.
- Subject is scheduled for ultrasound breast scan.
- Subject understands the study procedure.
Key exclusion criteria (14 listed)
- Age < 21 years or > 70 years.
- Subject undergo previous breast surgery
- Known blood coagulation disorders.
- Known cardiac disorders.
- Breast infection / breast abscess / breast pains.
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 breast scanningbreast scanning | Device | – |
Primary outcome
Occurrences of adverse events
Time frame: immediately
1 secondary outcome
Quality of ultrasound imaging
Time frame: within 1 day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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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.
Hanna Levy, PhD study director
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound breast scanning in people with Breast Cancer, run by Helix Medical Systems 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 9 Jun 2011. 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?
The study was stopped early. Results are not available in the source record.
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?
Occurrences of adverse events (time frame: immediately). 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 9 Jun 2011.