Mass LesionQTUSNCT02133417
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
An observational study of Mass Lesion, run by QT Ultrasound LLC at 2 sites in United States.
Trial summary
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Mass Lesion
- What is being tested?
- Quantitative Transmission Ultrasound
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jan 2016
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligibility for enrollment will be open to women of all races and ethnicities who have completed a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and have a lesion seen on HHUS corresponding to the XRM lesion(s). Women with a normal mammogram at the time of this evaluation are not eligible to participate. Women younger than 25 years of age will not be eligible to participate. Potential subjects must not be breastfeeding at the time of diagnostic breast imaging. Patients who have had breast cancer, breast surgeries, or interventional breast procedures in the past 12 months will not be eligible to enter the study.
Who may be able to join
- Female
- Age 25 or older
- A bra cup size of A through DDD
- Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s)
- Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst
- Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO) for one or both breasts
- Mammographically-detected lesion(s) seen on at least one mammographic view and a corresponding HHUS correlate(s)
Who cannot join
- Does not meet all Inclusion Criteria
- Currently breastfeeding
- History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration
- History of breast surgeries or interventional breast procedures in the past 12 months
- Normal mammogram at the time of this evaluation
- Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time
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- Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
- Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
- Body weight greater than 400 lbs. (180 kg)
- Has a concurrent disease or condition which in the judgment of the principal investigator disqualifies the subject, from participating in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elizabeth Wende Breast Care, LLC
Rochester, New York, 14620
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Mammographically-detected Lesion(s) to Evaluate the Non-inferiority of Digital Mammography (XRM) and Quantitative Transmission Ultrasound (QTUS) Together Compared to XRM and Hand Held Ultrasound (HHUS) Together in the Evaluation of Lesion(s) Detected With Diagnostic Mammography.
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
Read the detailed description
This is a prospective case collection study for the purpose of collecting cases for the subsequent Reader Studies at a minimum of two clinical sites.
Potential subjects will be recruited from a group of women who have undergone diagnostic mammography and demonstrate a mammographic lesion in at least one view. Approximately 300 women will be enrolled. Subjects will undergo QTUS following a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and will have a lesion seen on HHUS corresponding to the XRM lesion(s). Potential Subjects will be eligible for enrollment at the time the corresponding lesion is identified on HHUS. All subjects will undergo an ultrasound guided aspiration/biopsy with cytology to determine whether the lesion is a cyst or solid.
Each study site is projected to collect approximately 75 cyst cases and 75 solid cases for a total of 150 cases, stratified across the four (4) recognized breast tissue density categories with at least 50% of cases from subjects with heterogeneous and extremely dense breast compositions. The composition of the cyst cases at each site is projected to consist of 25 simple cysts and 50 complicated and complex cysts for a total of 75 cyst cases. All enrolled subjects will undergo ultrasound guided aspiration or biopsy or surgical excision, as applicable for the index lesion. Cytologic or histologic results for all lesions will be performed and collected.
- Conditions
- Mass Lesion
- Being tested
- Quantitative Transmission Ultrasound
- Keywords
- Quantitative Transmission Ultrasound, QTUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Transmission UltrasoundDevice
Also called QTUS, QT Ultrasound
Quantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass.
| Study group | Role | What they receive |
|---|---|---|
| Women | Women with mammographically-detected breast lesions Receives: Device: Quantitative Transmission Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology.
This is a prospective Case Collection study for the purpose of conducting subsequent Reader Studies. The primary objective for this prospective case collection study is to provide up to 300 cytology/pathology confirmed cases for subsequent Reader Studies.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass LesionStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- QT Ultrasound LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajni Natesan, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133417
- Sponsor's protocol ID
- 2013001
- Acronym
- QTUS
- Status last verified
- May 2018
- First submitted
- 6 May 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Mammographically-detected Lesion(s) to Evaluate the Non-inferiority of Digital Mammography (XRM) and Quantitative Transmission Ultrasound (QTUS) Together Compared to XRM and Hand Held Ultrasound (HHUS) Together in the Evaluation of Lesion(s) Detected With Diagnostic Mammography.
- ClinicalTrials.gov ID
- NCT02133417
- Acronym / sponsor ID
- QTUS / 2013001
- Conditions
- Mass Lesion
- Keywords
- Quantitative Transmission Ultrasound, QTUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- QT Ultrasound LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 May 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.
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
Detailed description
This is a prospective case collection study for the purpose of collecting cases for the subsequent Reader Studies at a minimum of two clinical sites.
Potential subjects will be recruited from a group of women who have undergone diagnostic mammography and demonstrate a mammographic lesion in at least one view. Approximately 300 women will be enrolled. Subjects will undergo QTUS following a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and will have a lesion seen on HHUS corresponding to the XRM lesion(s). Potential Subjects will be eligible for enrollment at the time the corresponding lesion is identified on HHUS. All subjects will undergo an ultrasound guided aspiration/biopsy with cytology to determine whether the lesion is a cyst or solid.
Each study site is projected to collect approximately 75 cyst cases and 75 solid cases for a total of 150 cases, stratified across the four (4) recognized breast tissue density categories with at least 50% of cases from subjects with heterogeneous and extremely dense breast compositions. The composition of the cyst cases at each site is projected to consist of 25 simple cysts and 50 complicated and complex cysts for a total of 75 cyst cases. All enrolled subjects will undergo ultrasound guided aspiration or biopsy or surgical excision, as applicable for the index lesion. Cytologic or histologic results for all lesions will be performed and collected.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | – | Device: Quantitative Transmission UltrasoundWomen with mammographically-detected breast lesions |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligibility for enrollment will be open to women of all races and ethnicities who have completed a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and have a lesion seen on HHUS corresponding to the XRM lesion(s). Women with a normal mammogram at the time of this evaluation are not eligible to participate. Women younger than 25 years of age will not be eligible to participate. Potential subjects must not be breastfeeding at the time of diagnostic breast imaging. Patients who have had breast cancer, breast surgeries, or interventional breast procedures in the past 12 months will not be eligible to enter the study.
Key inclusion criteria (7 listed)
- Female
- Age 25 or older
- A bra cup size of A through DDD
- Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s)
- Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst
Key exclusion criteria (10 listed)
- Does not meet all Inclusion Criteria
- Currently breastfeeding
- History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration
- History of breast surgeries or interventional breast procedures in the past 12 months
- Normal mammogram at the time of this evaluation
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 |
|---|---|---|
| Quantitative Transmission UltrasoundAlso: QTUS, QT UltrasoundQuantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass. | Device | Women |
Primary outcome
The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology.
Time frame: 12 months
This is a prospective Case Collection study for the purpose of conducting subsequent Reader Studies. The primary objective for this prospective case collection study is to provide up to 300 cytology/pathology confirmed cases for subsequent Reader Studies.
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 9 May 2018.
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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.
Rajni Natesan, MD study director
Chief Medical Officer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mass Lesion, run by QT Ultrasound LLC at 2 sites 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 7 inclusion and 10 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology. (time frame: 12 months). 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 May 2018.