Breast Cancer ScreeningNCT03517813
CESM ABMR Breast Cancer Screening Trial
An observational study of Breast Cancer Screening, run by University of Washington at 1 site in United States.
Trial summary
This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Contrast-enhanced Spectral Mammography (CESM)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 31 Dec 2022
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women referred for a clinical breast MRI.
Who may be able to join
- Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- Women aged ≥18 years at the time of enrollment
- Referred clinically for breast MRI for any indication
Who cannot join
- Known allergy or contraindication to iodinated contrast
- Are currently pregnant based on urine pregnancy test
- Have breast implants
- Are lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98102
About this study
Official title: Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.
Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).
Read more
Secondary Aims:
- Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
- Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).
- Conditions
- Breast Cancer Screening
- Being tested
- Contrast-enhanced Spectral Mammography (CESM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced Spectral Mammography (CESM)Device
Dual energy mammography images obtained after the administration of an intravenous contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Asymptomatic women at increased risk of breast cancer referred clinically for high risk screening breast MRI or women with newly diagnosed primary unilateral breast cancer referred for evaluation of extent of disease (EOD) in the index breast and screening of the contralateral breast.
All women enrolled on study will complete a clinical breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. Receives: Device: Contrast-enhanced Spectral Mammography (CESM) | |
| Cohort 2 | Women receiving MRI for any indication and for whom percutaneous biopsy with ultrasound or MRI guidance has been recommended.
All women enrolled on study will complete a standard breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. Receives: Device: Contrast-enhanced Spectral Mammography (CESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal interpretation rate
Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 2 years
Secondary outcomes (6)
Biopsy rate
Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 2 years
Positive predictive value for biopsy recommendation (PPV2)
Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 3 years
Negative predictive value
Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 3 years
Cancer detection rate
Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 3 years
Sensitivity
Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 2 years
Specificity
Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start3 Jan 2018
- Primary completion22 Jun 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Janie M Lee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517813
- Sponsor's protocol ID
- 9745
- Other IDs
- RG3016008, NCI-2021-12488
- Status last verified
- Jan 2023
- First submitted
- 27 Mar 2018
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT03517813
- Acronym / sponsor ID
- 9745
- Conditions
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 May 2018 (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 is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.
Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).
Secondary Aims:
- Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
- Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Contrast-enhanced Spectral Mammography (CESM)Asymptomatic women at increased risk of breast cancer referred clinically for high risk screening breast MRI or women with newly diagnosed primary unilateral breast cancer referred for evaluation of extent of disease (EOD) in the index breast and screening of the contralateral breast. All women enrolled on study will complete a clinical breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. |
| Cohort 2 | – | Device: Contrast-enhanced Spectral Mammography (CESM)Women receiving MRI for any indication and for whom percutaneous biopsy with ultrasound or MRI guidance has been recommended. All women enrolled on study will complete a standard breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women referred for a clinical breast MRI.
Key inclusion criteria (3 listed)
- Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- Women aged ≥18 years at the time of enrollment
- Referred clinically for breast MRI for any indication
Key exclusion criteria (4 listed)
- Known allergy or contraindication to iodinated contrast
- Are currently pregnant based on urine pregnancy test
- Have breast implants
- Are lactating
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 |
|---|---|---|
| Contrast-enhanced Spectral Mammography (CESM)Dual energy mammography images obtained after the administration of an intravenous contrast agent | Device | Cohort 1, Cohort 2 |
Primary outcome
Abnormal interpretation rate
Time frame: 2 years
Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)
6 secondary outcomes
Biopsy rate
Time frame: 2 years
Positive predictive value for biopsy recommendation (PPV2)
Time frame: 3 years
Negative predictive value
Time frame: 3 years
Cancer detection rate
Time frame: 3 years
Sensitivity
Time frame: 2 years
Specificity
Time frame: 2 years
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 6 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Janie M Lee principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Cancer Screening, run by University of Washington 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 4 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 6 Jan 2023. 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 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?
Abnormal interpretation rate (time frame: 2 years). 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 6 Jan 2023.