Breast CancerNCT01086514
Digital Mammography for the Detection and Preoperative Staging of Breast Cancer
A study testing Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2012
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with newly diagnosed unilateral breast cancer proven through core biopsy or FNA who are planned to have (preoperative) MRI within 30 days of DE CEDM to assess extent of disease/multifocality. (All women will have bilateral digital mammography as per standard of care.) The preoperative MRI will be based on the surgeon's recommendation.
- Both breasts are present.
- Women consenting to a bilateral DE CEDM examination.
Who cannot join
- Women under 21.
- Women who have already had a lumpectomy. (Index lesion has been removed and therefore, not evaluable for the purpose of this study.)
- Women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.
- Known pregnancy.
- Women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent.
- Women with breast implants.
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- Women with pacemakers.
- Women with aneurysm clips that don't allow for MRI.
- Women too claustrophobic to undergo MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer
Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients.
However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.
- Conditions
- Breast Cancer
- Being tested
- Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)
- Keywords
- Breast, mammography, MRI, Digital Mammography, 10-024
- 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 Digital Mammography (DE CEDM)Procedure or surgery
Each patient will have: Bilateral digital mammography, Bilateral Breast MRI, Bilateral Contrast Enhanced Digital Mammography. The latter examination is the only change in patient management. An additional contrast injection is involved. Results of the DE CEDM will be compared with routine digital mammography and breast MRI. The reference standard is pathology. If surgery is to be done; every attempt will be made to perform all imaging exams within 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) | Experimental | In this study we will perform Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) on patients with newly diagnosed breast cancer using a dedicated research system, derived from a standard digital mammography unit and review workstation (Senographe DS and SenoAdvantage) modified to deliver the required dual energy paired exposures and visualization of combined images. Receives: Procedure: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate additional measures of accuracy of DE CEDM and MRI, such as the predictive values and ROC curves where applicable, for detecting multifocal or multicentric disease in the ipsilateral breast.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Measured: within 3 weeks of each other and within 30 days of surgery
Secondary outcomes (2)
To compare the sensitivity and specificity of DE CEDM with that of breast MRI in the detection of disease in the contralateral breast.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Measured: within 3 weeks of each other and within 30 days of surgery
To estimate the interobserver variability of DE CEDM.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Measured: within 3 weeks of each other and within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionOct 2012
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 Memorial Sloan Kettering 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Maxine Jochelson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086514
- Sponsor's protocol ID
- 10-024
- Status last verified
- Sep 2015
- First submitted
- 11 Mar 2010
- Last updated
- 30 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer
- ClinicalTrials.gov ID
- NCT01086514
- Acronym / sponsor ID
- 10-024
- Conditions
- Breast Cancer
- Keywords
- Breast, mammography, MRI, Digital Mammography, 10-024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Mar 2010 (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.
Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients.
However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) | Experimental | Procedure: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)In this study we will perform Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) on patients with newly diagnosed breast cancer using a dedicated research system, derived from a standard digital mammography unit and review workstation (Senographe DS and SenoAdvantage) modified to deliver the required dual energy paired exposures and visualization of combined images. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with newly diagnosed unilateral breast cancer proven through core biopsy or FNA who are planned to have (preoperative) MRI within 30 days of DE CEDM to assess extent of disease/multifocality. (All women will have bilateral digital mammography as per standard of care.) The preoperative MRI will be based on the surgeon's recommendation.
- Both breasts are present.
- Women consenting to a bilateral DE CEDM examination.
Key exclusion criteria (9 listed)
- Women under 21.
- Women who have already had a lumpectomy. (Index lesion has been removed and therefore, not evaluable for the purpose of this study.)
- Women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.
- Known pregnancy.
- Women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent.
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 Digital Mammography (DE CEDM)Each patient will have: Bilateral digital mammography, Bilateral Breast MRI, Bilateral Contrast Enhanced Digital Mammography. The latter examination is the only change in patient management. An additional contrast injection is involved. Results of the DE CEDM will be compared with routine digital mammography and breast MRI. The reference standard is pathology. If surgery is to be done; every attempt will be made to perform all imaging exams within 30 days. | Procedure or surgery | Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) |
Primary outcome
To estimate additional measures of accuracy of DE CEDM and MRI, such as the predictive values and ROC curves where applicable, for detecting multifocal or multicentric disease in the ipsilateral breast.
Time frame: within 3 weeks of each other and within 30 days of surgery
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
2 secondary outcomes
To compare the sensitivity and specificity of DE CEDM with that of breast MRI in the detection of disease in the contralateral breast.
Time frame: within 3 weeks of each other and within 30 days of surgery
To estimate the interobserver variability of DE CEDM.
Time frame: within 3 weeks of each other and within 30 days of surgery
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 30 Sep 2015.
- Memorial Sloan Kettering 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.
Maxine Jochelson, MD principal investigator
Memorial Sloan Kettering Cancer 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 Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) in people with Breast Cancer, run by Memorial Sloan Kettering 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 3 inclusion and 9 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 30 Sep 2015. 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?
To estimate additional measures of accuracy of DE CEDM and MRI, such as the predictive values and ROC curves where applicable, for detecting multifocal or multicentric disease in the ipsilateral breast. (time frame: within 3 weeks of each other and within 30 days of surgery). 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 30 Sep 2015.