Using advanced ultrasound technology to improve breast cancer diagnosis and treatment
Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients
This study is testing a new ultrasound technique to see if it can help doctors better understand and treat breast cancer in patients receiving chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RWTH Aachen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aachen, NRW) |
| Trial ID | NCT05445050 on ClinicalTrials.gov |
What this trial studies
This project aims to adapt a super-resolution ultrasound imaging technique called motion-model Ultrasound Localization Microscopy (mULM) for clinical use in breast cancer patients. The study involves developing a scan protocol to assess tumor characteristics and response to neoadjuvant chemotherapy. Participants will undergo ultrasound scans using a contrast agent, and the resulting images will be analyzed to evaluate tumor perfusion and microvasculature. The findings will be validated through histological examinations, with the goal of optimizing the ultrasound examination protocol.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed primary breast cancer or highly suspected primary breast cancer.
Not a fit: Patients with certain medical conditions such as severe cardiovascular issues, acute infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of breast cancer diagnosis and treatment monitoring, leading to better patient outcomes.
How similar studies have performed: While the application of mULM in clinical settings is relatively novel, similar ultrasound techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aachen, NRW
- Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöR — Aachen, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Elmar Stickeler, Prof Dr. med — RWTH Aachen University Hospital
- Study coordinator: Elmar Stickeler, Prof Dr. med
- Email: estickeler@ukaachen.de
- Phone: +492418088400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.