An interventional study of Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-09-30.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 82 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: 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.
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
Time frame: within 3 weeks of each other and within 30 days of surgery
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
Time frame: 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
Time frame: within 3 weeks of each other and within 30 days of surgery
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center