Motion-model Ultrasound Localization Microscopy (mULM) for Diagnostics and Therapy Monitoring in Breast Carcinoma

Not Applicable

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00023954
• Lead Sponsor: Klinik für Gynäkologie und Geburtshilfe RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

1. patients with histologically confirmed primary breast carcinoma including all intrinsic subtypes (study part A and B) and patients with high-grade suspicion of primary breast carcinoma (study part C).
2. treatment with neoadjuvant chemotherapy (study part A and B)
3. written informed consent
4. subjects who are legally competent and mentally able to comply with the instructions of the study personnel

Exclusion Criteria

1. minority
2. hypersensitivity / allergy to ultrasound contrast agent or its components sulfur hexafluoride, macrogol 4000, colfosceril stearate, 1-(1,2-dipalmitoyl-3-sn-phosphatidyl)glycerol sodium salt palmitic acid
3. right-left shunt
4. signs of cardiovascular instability
5. acute endocarditis
6. artificial heart valves
7. acute systemic inflammation and/or sepsis
8. overactive coagulation status and/or recent thromboembolism
9. end-stage renal or hepatic disease
10. severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHG)
11. uncontrolled systemic hypertension
12. acute respiratory distress syndrome
13. pregnant women
14. persons who are institutionalized by administrative or judicial order
15. persons who are in a dependent or employment relationship with the sponsor or investigator
16. alcohol and drug abuse
17. expected non-compliance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The goal of this project is to adapt the mULM to clinical application to study the discrimination of benign and malignant breast cancer tumors and the prediction and monitoring of breast cancer responses to neoadjuvant chemotherapy in an exploratory patient study.