Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
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• 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

Locations
Other Locations
Germany
Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöR
RECRUITING
Aachen
Contact Information
Primary
Elmar Stickeler, Prof Dr. med
estickeler@ukaachen.de
+492418088400
Backup
Fabian Kiessling, Prof Dr. med
fkiessling@ukaachen.de
+49 241 80 80117
Time Frame
Start Date: 2021-04-26
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 74
Treatments
Other: clinical application of mULM to support breast cancer diagnosis and therapy
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.
Related Therapeutic Areas
Sponsors
Leads: RWTH Aachen University

This content was sourced from clinicaltrials.gov