Breast CancerNCT02275871
Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer
A study testing MRI and CESM in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI and CESM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2020
- Phase
- Interventional
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Age > or equal to 30 years
- High risk (>20% lifetime risk)
- Has a bilateral mammogram within the last 7 months
- Has had a same day high risk screening MRI
Who cannot join
- Participants who have a known allergy or contraindication to iodinated contrast.
- Participants who have a known allergy to food or medications.
- Participants who have renal insufficiency or failure.
- Participants who are pregnant or breastfeeding.
- Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI
This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.
Read the detailed description
This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.
Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.
In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.
We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- MRI, CESM
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
High risk screening MRI will be performed as part of the patient's routine care.
CESMOther
Also called Contrast Enhanced Spectral Mammography
After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.
| Study group | Role | What they receive |
|---|---|---|
| MRI and CESM | Experimental | High risk patients will get standard of care screening MRI and study CESM on the same day. Receives: Other: MRI; Other: CESM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity
All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Didn't have funding to support the study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Jordana Phillips, MD, Beth Israel Deaconess Medical Center
- Investigators
- Jordana Phillips, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275871
- Sponsor's protocol ID
- 14-225
- Status last verified
- Mar 2020
- First submitted
- 20 Oct 2014
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI
- ClinicalTrials.gov ID
- NCT02275871
- Acronym / sponsor ID
- 14-225
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Didn't have funding to support the study design
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Nov 2014
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 27 Oct 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.
This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.
Detailed description
This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.
Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.
In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.
We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for 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 |
|---|---|---|
| MRI and CESM | Experimental | Other: MRI, Other: CESMHigh risk patients will get standard of care screening MRI and study CESM on the same day. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women
- Age > or equal to 30 years
- High risk (>20% lifetime risk)
- Has a bilateral mammogram within the last 7 months
- Has had a same day high risk screening MRI
Key exclusion criteria (5 listed)
- Participants who have a known allergy or contraindication to iodinated contrast.
- Participants who have a known allergy to food or medications.
- Participants who have renal insufficiency or failure.
- Participants who are pregnant or breastfeeding.
- Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
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 |
|---|---|---|
| MRIHigh risk screening MRI will be performed as part of the patient's routine care. | Other | MRI and CESM |
| CESMAlso: Contrast Enhanced Spectral MammographyAfter the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities. | Other | MRI and CESM |
Primary outcome
Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity
Time frame: 4 years
All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).
Results and safety
The study was stopped early (reason given: Didn't have funding to support the study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
Jordana Phillips, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and CESM in people with Breast Cancer, run by Beth Israel Deaconess Medical 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 5 inclusion and 5 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 16 Mar 2020. 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: Didn't have funding to support the study design). 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?
Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity (time frame: 4 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 16 Mar 2020.