Clinical trial · Interventional
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Digital Mammography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CEM)
- description
- Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.
- interventionNames
- Procedure: Contrast Enhanced Digital Mammography
Primary outcomes (12)
- measure
- Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
- timeFrame
- Up to 1 year
- description
- The total number of suspicious and benign lesions on each modality (mammogram+ultrasound \[MM+US\] and CEM) will be calculated and compared to a final tissue diagnosis independently.
- measure
- Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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?
References
Publications (0)
Data not yet available