Breast DiseasesNCT02997540
Effect of Body Position and Probe Position on the Localization of Breast Mass
An observational study of Breast Diseases, run by MetriTrack, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Breast Diseases
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jan 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Females of any ethnic group who meet all inclusion and none of the exclusion criteria will be eligible for enrollment
Who may be able to join
- Female
- 21-70 years of age
- Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination
Who cannot join
- Women with cardiac pacemaker or portable defibrillator
- Women with known breast cancer or suspicious lesions
- Pregnant and lactating women
- Women who have breast implant(s)
- Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass.
- Women with the target finding to be mapped within a distance of 4 cm from patient's nipple.
Show all 9Show fewer
- Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets).
- Women with history of allergy to medical-grade adhesive tape or ultrasound gel
- Women whose weight is over 250 pounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination
The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.
Read the detailed description
The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.
- Conditions
- Breast Diseases
- Keywords
- female breast lesion, ultrasound examination
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| female breast ultrasound exam | females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
movement of a given ultrasound breast lesion
movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations
Measured: study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Successfully obtained sufficient data to complete this research project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetriTrack, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997540
- Sponsor's protocol ID
- BVN G-1000
- Status last verified
- Jul 2021
- First submitted
- 7 Dec 2016
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination
- ClinicalTrials.gov ID
- NCT02997540
- Acronym / sponsor ID
- BVN G-1000
- Conditions
- Breast Diseases
- Keywords
- female breast lesion, ultrasound examination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Successfully obtained sufficient data to complete this research project.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MetriTrack, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 20 Dec 2016 (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.
The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.
Detailed description
The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female breast ultrasound exam | – | –females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females of any ethnic group who meet all inclusion and none of the exclusion criteria will be eligible for enrollment
Key inclusion criteria (3 listed)
- Female
- 21-70 years of age
- Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination
Key exclusion criteria (9 listed)
- Women with cardiac pacemaker or portable defibrillator
- Women with known breast cancer or suspicious lesions
- Pregnant and lactating women
- Women who have breast implant(s)
- Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
movement of a given ultrasound breast lesion
Time frame: study completion, an average of 1 day
movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations
Results and safety
The study was stopped early (reason given: Successfully obtained sufficient data to complete this research project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Breast Diseases, run by MetriTrack, Inc. 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 3 inclusion and 9 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 21 Jul 2021. 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?
The study was stopped early (reason given: Successfully obtained sufficient data to complete this research project.). 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?
movement of a given ultrasound breast lesion (time frame: study completion, an average of 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 21 Jul 2021.