Breast CancerNCT02995980
Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
A study testing Dual-Energy Contrast-Enhanced (DECE) mammography and digital mammography in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dual-Energy Contrast-Enhanced (DECE) mammography and digital mammography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- At least 19 years old
- Glomerular filtration rate> 60
- Heterogeneously or extremely dense breasts (BI-RADS category c or d).
Who cannot join
- History of iodinated contrast allergy
- Pregnant or lactating as determined by routine standard practice
- Personal history of breast cancer
- History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
- History of prior breast reduction mammoplasty surgery
- History of prior breast augmentation surgery
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.
Read the detailed description
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer
- Conditions
- Breast Cancer
- Being tested
- Dual-Energy Contrast-Enhanced (DECE) mammography, digital mammography
- Keywords
- breast cancer screening, dense breasts, dual-energy contrast-enhanced digital mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy Contrast-Enhanced (DECE) mammographyDevice
Also called Contrast-enhanced spectral mammography (CESM), Contrast-enhanced mammography
Contrast mammography
digital mammographyDevice
Also called full field digital mammography
routine digital mammography
| Study group | Role | What they receive |
|---|---|---|
| Contrast enhanced mammography vs standard digital mammogram | Experimental | Contrast-enhanced spectral mammography for the detection breast cancer . Receives: Device: Dual-Energy Contrast-Enhanced (DECE) mammography; Device: digital mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Accuracy of Contrast Mammography
•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
Measured: 1 year
Number of Participants With Cancer Detected
•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).
Measured: 1 year
Secondary outcomes (1)
Number of Call Backs With Contrast Mammography
•The patients identified for additional imaging based on unconfirmed findings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Lancaster, MD, University of Alabama at Birmingham
- Investigators
- Heidi R Umphrey, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995980
- Sponsor's protocol ID
- F141210004
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2016
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)
- ClinicalTrials.gov ID
- NCT02995980
- Acronym / sponsor ID
- F141210004
- Conditions
- Breast Cancer
- Keywords
- breast cancer screening, dense breasts, dual-energy contrast-enhanced digital mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 25 Sep 2019
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 feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.
Detailed description
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast enhanced mammography vs standard digital mammogram | Experimental | Device: Dual-Energy Contrast-Enhanced (DECE) mammography, Device: digital mammographyContrast-enhanced spectral mammography for the detection breast cancer . |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- At least 19 years old
- Glomerular filtration rate> 60
- Heterogeneously or extremely dense breasts (BI-RADS category c or d).
Key exclusion criteria (7 listed)
- History of iodinated contrast allergy
- Pregnant or lactating as determined by routine standard practice
- Personal history of breast cancer
- History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
- History of prior breast reduction mammoplasty surgery
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 |
|---|---|---|
| Dual-Energy Contrast-Enhanced (DECE) mammographyAlso: Contrast-enhanced spectral mammography (CESM), Contrast-enhanced mammographyContrast mammography | Device | Contrast enhanced mammography vs standard digital mammogram |
| digital mammographyAlso: full field digital mammographyroutine digital mammography | Device | Contrast enhanced mammography vs standard digital mammogram |
Primary outcome
Percent Accuracy of Contrast Mammography
Time frame: 1 year
•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
Number of Participants With Cancer Detected
Time frame: 1 year
•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).
1 secondary outcome
Number of Call Backs With Contrast Mammography
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Heidi R Umphrey, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Energy Contrast-Enhanced (DECE) mammography and digital mammography in people with Breast Cancer, run by University of Alabama at Birmingham 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 4 inclusion and 7 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 25 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Accuracy of Contrast Mammography (time frame: 1 year). The study lists 2 primary outcomes in all. 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 25 Sep 2019.