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mULM to Support Breast Cancer Diagnosis and Therapy

NCT05445050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Primary Breast Cancer

Interventions

DIAGNOSTIC_TEST

Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)

Part A: performing CEUS with the contrast agent SonoVue® at two different doses and two different injection speeds in participants with primary breast cancer Part B: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants undergoing neoadjuvant chemotherapy Part C: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants with lesions of unknown dignity

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Elmar Stickeler, Prof Dr. med · RWTH Aachen University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2024-06-01
Completion
2024-10-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445050 on ClinicalTrials.gov