Clinical trial · Interventional
KVUS at Neoadjuvant CTx of Breast Cancer
Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
NCT03385200CI-TRIAL-00030951unknownPhase 3ClinicalTrials.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)
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
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 |
|---|---|---|---|
| Early Primary Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SonoVue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
- interventionNames
- Drug: SonoVue
- type
- NO_INTERVENTION
- label
- B
- description
- Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound
Primary outcomes (3)
- measure
- Tumor size reduction (1)
- timeFrame
- 18 / 24 weeks
- description
- pCR (pathohistological complete remission)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * age \> 18 yrs * histologically confirmed primary breast cancer including all intrinsic subtypes * treatment with neoadjuvant chemotherapy * persons who are legally competent and mentally able to follow the instructions of the study team Exclusion Criteria: * hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid * right-left shunt, * severe pulmonary hypertension (pulmonary arterial pressure \> 90 mmHg) * uncontrolled systemic hypertension * acute respiratory distress syndrome * pregnancy * commitment of the patient to any resident institution by order of any court or authority * expectation of missing compliance * alcohol or drug abuse * patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
References
Publications (0)
Data not yet available
No reference posted for this study.