Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings (NCT03929783) | Clinical Trial Compass
CompletedNot Applicable
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
United States107 participantsStarted 2020-06-23
Plain-language summary
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.
Who can participate
Age range
30 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
* Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or \> 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
* Scheduled for imaging guided percutaneous needle biopsy.
* Provide signed and dated informed consent form.
* If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.
Exclusion Criteria:
* \< 1 cm span of calcifications without an ultrasound correlate.
* Pregnant patients.
* Patients with known allergy to iodinated contrast material.
* If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age:
* Have you ever been told you have renal problems?
* Have you ever been told you have protein in your urine?
* Do you have high blood pressure?
* Do you have diabetes?
* Do you have gout?
* Have you ever had kidney surgery?
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
Timeframe: Up to 1 year
2
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
Timeframe: Up to 1 year
3
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
Timeframe: Up to 1 year
4
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
Timeframe: Up to 1 year
5
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
Timeframe: Up to 1 year
6
Specificity of US to classify a lesion as benign, probably benign, or suspicious