Clinical trial · Interventional
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor determined there was sufficient material collected to answer the study questions.
Summary
Brief summary (as posted)
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CE-BMRI | Device | — | UNRESOLVED |
| DE-CEDM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CE-BMRI
- description
- Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
- interventionNames
- Device: CE-BMRI
- Device: DE-CEDM
Primary outcomes (5)
- measure
- Completion of CE-BMRI and DE-CEDM
- timeFrame
- Approximately 8 weeks
- description
- Subjects have completed both CE-BMRI and DE-CEDM scan types
- measure
- Average Maximum Lesion Size by CE-BMRI Scan
- timeFrame
- Within 1 week of CE-BMRI scan
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Woman 21 years of age or older * The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained. * Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days. * Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis. Exclusion Criteria: * Woman who has already had a lumpectomy for the index lesion. * Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy. * Woman who is pregnant or who believe she may be pregnant. * Woman who has breast implant. * Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).
References
Publications (0)
Data not yet available