Breast CancerABUSNCT02488187
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients
A study testing ABUS in people with Breast Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ABUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
- Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
- Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
- If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
- If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
- The MRI and ABUS exam must be obtained within 2 weeks of each other.
Who cannot join
- Males
- Pregnant women
- Lactating women
- Patients < 18 and > 100 years of age
- Patients with breast implants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.
Read the detailed description
This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.
- Conditions
- Breast Cancer
- Being tested
- ABUS
- Keywords
- Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABUSDevice
Automated breast ultrasound
| Study group | Role | What they receive |
|---|---|---|
| ABUS vs MRI (ultrasound when indicated) | Other | To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients. Receives: Device: ABUS |
| ABUS vs mammography (ultrasound when indicated) | Other | To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed. Receives: Device: ABUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionDec 2017 (estimated)
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 University of Kansas Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488187
- Sponsor's protocol ID
- ABUS
- Acronym
- ABUS
- Status last verified
- Jul 2016
- First submitted
- 30 Jun 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02488187
- Acronym / sponsor ID
- ABUS / ABUS
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, MRI, Mammogram, Whole Breast Sonogram, ABUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Jul 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.
Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.
Detailed description
This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABUS vs MRI (ultrasound when indicated) | Other | Device: ABUSTo compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients. |
| ABUS vs mammography (ultrasound when indicated) | Other | Device: ABUSTo compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
- Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
- Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
- If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
- If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
Key exclusion criteria (5 listed)
- Males
- Pregnant women
- Lactating women
- Patients < 18 and > 100 years of age
- Patients with breast implants
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 |
|---|---|---|
| ABUSAutomated breast ultrasound | Device | ABUS vs MRI (ultrasound when indicated), ABUS vs mammography (ultrasound when indicated) |
Primary outcome
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
Time frame: 1 day
Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABUS in people with Breast Cancer, run by University of Kansas Medical Center at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 19 Jan 2017. 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 United States. 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?
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?
Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging (time frame: 1 day). 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 19 Jan 2017.