mULM to Support Breast Cancer Diagnosis and Therapy

NCT05445050 | Unknown

• 2 other identifiers: 351-19DRKS00023954
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer; neoadjuvant chemotherapy; ultrasound; microbubbles

Outcome Measures

Primary Outcomes (4)

• Relative blood volume

  Relative blood volume in % - describes the degree of vascularization - measured with mULM

  Study Part A & C: approximately 1 day before surgical removal of tumor

• Blood flow

  Blood flow in mm/s - measured with mULM

  Study Part A & C: approximately 1 day before surgical removal of tumor

• Change of relative blood volume

  Change of relative blood volume in %

  Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)

• Change of blood flow

  Change of blood flow in mm/s

  Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)

Secondary Outcomes (1)

• Change of tumor size

  Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)

Study Arms (1)

clinical application of mULM to support breast cancer diagnosis and therapy

OTHER

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.

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

Interventions

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

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

clinical application of mULM to support breast cancer diagnosis and therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöR

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elmar Stickeler, Prof Dr. med

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elmar Stickeler, Prof Dr. med

CONTACT

+492418088400; estickeler@ukaachen.de

Fabian Kiessling, Prof Dr. med

CONTACT

+49 241 80 80117; fkiessling@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Elmar Stickeler, RWTH Aachen University

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: July 6, 2022
• Study Start: April 26, 2021
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)