Breast CarcinomaNCT05005936
Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment. Breast ultrasonography is operator dependent and time-intensive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 29 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer or suspicion of breast cancer seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
Who may be able to join
- The subjects to be studied will include patients seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
- With breast cancer or suspicion of breast cancer
- Male or female who is older than 18 years of age
- Of any race
- Who consent to obtain technologist performed breast ultrasound and automated breast ultrasound
- English and non-English speakers (with language interpreter to assist in translation for non-English speakers)
Who cannot join
- Patient who is less than 18 years of age
- Imaging obtained outside of MD Anderson TMC
- Surgery pathology from outside of MD Anderson will be excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Performance of Automated Breast Ultrasonography (ABUS) to Hand-Held Breast Ultrasonography (WBUS) in Breast Cancer Treatment Response Assessment in a Tertiary Cancer Center: A Prospective Study
This study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment. Breast ultrasonography is operator dependent and time-intensive. Automated breast ultrasonography scanners were developed to allow standardization of ultrasound scanning and scanning to be performed by any technologist, with or without previous ultrasound experience, without physician involvement. This study may validate the use of the automated breast ultrasonography.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate and compare the accuracy of automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) in predicting pathology complete response (pCR) with relative tumor volume change, using the receiver operating characteristic (ROC) curve analysis.
SECONDARY OBJECTIVES:
- To evaluate the reproducibility of tumor volume measurements obtained by ABUS and handheld WBUS, respectively, using data collected at baseline for initial staging.
II. To assess the agreement in relative tumor volume change (RC) (end-of-treatment versus [vs.] pre-treatment) between ABUS and WBUS.
III. To estimate and compare the following diagnostic measures for ABUS and WBUS: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
OUTLINE:
Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).
- Conditions
- Breast Carcinoma
- Being tested
- Ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound
Undergo ABUS
UltrasonographyProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound
Undergo WBUS
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (ABUS, WBUS) | Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment). Receives: Procedure: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic (ROC) curve
Will compute relative tumor volume change for both automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) and estimate pathology complete response ROC curves for each. Will estimate the areas under the ROC curves along with 95% confidence intervals and then compare the values statistically.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Tumor volume
Will compute the intraclass correlation coefficient for each method along with 95% confidence intervals and then compare these estimates.
Measured: through study completion, an average of 1 year
Relative tumor volume change
Will compute the relative change in tumor volume for ABUS and WBUS and assess their agreement using the Bland-Altman approach.
Measured: through study completion, an average of 1 year
Sensitivity
The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
Measured: through study completion, an average of 1 year
Specificity
The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
Measured: through study completion, an average of 1 year
Positive predictive value
Measured: through study completion, an average of 1 year
Negative predictive value
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start29 Nov 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Why it stopped: No participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monica L Huang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005936
- Sponsor's protocol ID
- 2020-0831
- Other IDs
- NCI-2021-05381, 2020-0831
- Status last verified
- May 2022
- First submitted
- 30 Jul 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Performance of Automated Breast Ultrasonography (ABUS) to Hand-Held Breast Ultrasonography (WBUS) in Breast Cancer Treatment Response Assessment in a Tertiary Cancer Center: A Prospective Study
- ClinicalTrials.gov ID
- NCT05005936
- Acronym / sponsor ID
- 2020-0831
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- 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.
This study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment. Breast ultrasonography is operator dependent and time-intensive. Automated breast ultrasonography scanners were developed to allow standardization of ultrasound scanning and scanning to be performed by any technologist, with or without previous ultrasound experience, without physician involvement. This study may validate the use of the automated breast ultrasonography.
Detailed description
PRIMARY OBJECTIVE:
- To estimate and compare the accuracy of automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) in predicting pathology complete response (pCR) with relative tumor volume change, using the receiver operating characteristic (ROC) curve analysis.
SECONDARY OBJECTIVES:
- To evaluate the reproducibility of tumor volume measurements obtained by ABUS and handheld WBUS, respectively, using data collected at baseline for initial staging.
II. To assess the agreement in relative tumor volume change (RC) (end-of-treatment versus [vs.] pre-treatment) between ABUS and WBUS.
III. To estimate and compare the following diagnostic measures for ABUS and WBUS: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
OUTLINE:
Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (ABUS, WBUS) | – | Procedure: UltrasonographyPatients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer or suspicion of breast cancer seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
Key inclusion criteria (6 listed)
- The subjects to be studied will include patients seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
- With breast cancer or suspicion of breast cancer
- Male or female who is older than 18 years of age
- Of any race
- Who consent to obtain technologist performed breast ultrasound and automated breast ultrasound
Key exclusion criteria (3 listed)
- Patient who is less than 18 years of age
- Imaging obtained outside of MD Anderson TMC
- Surgery pathology from outside of MD Anderson will be excluded from this study
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 |
|---|---|---|
| UltrasonographyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasoundUndergo ABUS | Procedure or surgery | Ancillary-Correlative (ABUS, WBUS) |
| UltrasonographyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasoundUndergo WBUS | Procedure or surgery | Ancillary-Correlative (ABUS, WBUS) |
Primary outcome
Area under the receiver operating characteristic (ROC) curve
Time frame: through study completion, an average of 1 year
Will compute relative tumor volume change for both automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) and estimate pathology complete response ROC curves for each. Will estimate the areas under the ROC curves along with 95% confidence intervals and then compare the values statistically.
6 secondary outcomes
Tumor volume
Time frame: through study completion, an average of 1 year
Relative tumor volume change
Time frame: through study completion, an average of 1 year
Sensitivity
Time frame: through study completion, an average of 1 year
Specificity
Time frame: through study completion, an average of 1 year
Positive predictive value
Time frame: through study completion, an average of 1 year
Negative predictive value
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Monica L Huang principal investigator
M.D. Anderson Cancer Center
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 Carcinoma, run by M.D. Anderson Cancer 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 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: withdrawn, as of the sponsor's last update on 27 May 2022. 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 withdrawn before enrolling participants, so there are no results.
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?
Area under the receiver operating characteristic (ROC) curve (time frame: through study completion, an average of 1 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 27 May 2022.