Clinical trial · Interventional
mULM to Support Breast Cancer Diagnosis and Therapy
Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients
- 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)
The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor response to neoadjuvant chemotherapy in participants with a primary breast cancer diagnosis as well as for the differentiation of benign and malignant breast tumors in participants with lesions of unknown dignity.
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 |
|---|---|---|---|
| Primary Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- clinical application of mULM to support breast cancer diagnosis and therapy
- description
- The study arm includes three parts A, B and C. In part A, the scan protocol, including the injection of the clinically approved contrast agent SonoVue® and the data acquisition time range, is optimized based on the mULM measurements of participants with primary breast cancer. The following part B consists of 2D-mULM measurements applied to triple-negative breast cancer patients throughout their neoadjuvant chemotherapy cycles with the aim to evaluate to which degree 2D-mULM allows for an assessment of the tumor response during therapy. In the last part C, participants with neoplasms of uncertain dignity will be investigated by 2D- and 3D-mULM measurements and the accuracy of differentiation between the lesions assessed.
- interventionNames
- Diagnostic Test: Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)
Primary outcomes (4)
- measure
- Relative blood volume
- timeFrame
- Study Part A & C: approximately 1 day before surgical removal of tumor
- description
- Relative blood volume in % - describes the degree of vascularization - measured with mULM
Eligibility
Eligibility (as posted)
- Sex
- Female
- 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 (study parts A and B) * highly suspected primary breast cancer (study part C) * treatment with neoadjuvant chemotherapy (study part B) * persons who are legally competent and mentally able to follow the instructions of the study team Exclusion Criteria: * younger than 18 years * hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid * right-left shunt, * signs of cardiovascular instability * acute endocarditis * artificial heart valves * acute systemic inflammation and/or sepsis * overactive coagulation status and/or recent thromboembolic events * end stage of liver and kidney diseases * 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