Clinical trial · Observational
A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer
Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
NCT05990478CI-TRIAL-00089966withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Challenges to participant accrual
Summary
Brief summary (as posted)
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.
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 |
|---|---|---|---|
| Breast MRI | Diagnostic Test | — | UNRESOLVED |
| Contrast-Enhanced Mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Breast Cancer
- description
- Participants will have a diagnosis of breast cancer
- interventionNames
- Diagnostic Test: Contrast-Enhanced Mammography
- Diagnostic Test: Breast MRI
Primary outcomes (1)
- measure
- Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
- timeFrame
- Up to 1 year
- description
- compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any women \>18 years of age at time of informed consent * Diagnosed with breast cancer and schedule for NAT Exclusion Criteria: * History of kidney disease, creatinine level \>1.3 or eGFR \<45. * Known allergic reaction to gadolinium or iodinated contrast media. * Contraindication to contrast-enhanced breast MRI. * Lesion not included in the field of view of either pre- or post-NAT MRI or CEM * Presence of pacemakers or automated implantable cardioverter defibrilator * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.