Clinical trial · Observational
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
Imaging Quality and Potential Clinical Relevance of Phase Contrast
NCT06489665CI-TRIAL-00085548recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.
Conditions
Conditions (3)
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 |
| Image | — | UNRESOLVED | — |
| Microcalcification | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental Intervention | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Mammography finding
- description
- Describes the mammography finding in patients prior breast surgery
- interventionNames
- Diagnostic Test: Experimental Intervention
- label
- Bellona
- description
- Describes the finding in the breast tissue samples
- interventionNames
- Diagnostic Test: Experimental Intervention
Primary outcomes (1)
- measure
- Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.
- timeFrame
- 30 month
- description
- The standard reference will be the histologic specimen after biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria -Phase 0: * \>18 years * Mastectomy, tumorectomy or biopsy planned * Informed consent of the patient Inclusion criteria -Phase 1: * \>18 years * BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy); * Scheduled for mastectomy or breast conserving surgery with radiotherapy. * Informed consent of the patient Inclusion criteria - Phase 2: * \>40 years * undergoing mammography for screening or diagnostic purpose. * Informed consent of the patient Exclusion Criteria: * Exclusion criteria for all three Phases: * Breast implants. The women will be asked, if they have a breast-implant. * Inability to understand the study procedure due to cognitive or linguistic deficits. Exclusion criteria for patients, participating in Phase 1 and Phase 2: * Pregnancy * Breast-feeding. * Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
References
Publications (0)
Data not yet available
No reference posted for this study.