JOURNAL ONKOLOGIE – STUDIE

mULM to Support Breast Cancer Diagnosis and Therapy

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05445050

Studienbeginn:
April 2021

Letztes Update:
20.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
RWTH Aachen University

Collaborator:
-

Studienleiter

Elmar Stickeler, Prof Dr. med
Principal Investigator
RWTH Aachen University Hospital

Kontakt

Elmar Stickeler, Prof Dr. med
Kontakt:
Phone: +492418088400
E-Mail: estickeler@ukaachen.de» Kontaktdaten anzeigen

Fabian Kiessling, Prof Dr. med
Kontakt:
Phone: +49 241 80 80117
E-Mail: fkiessling@ukaachen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöR
52074 Aachen
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Elmar Stickeler
Phone: +492418088400
E-Mail: estickeler@ukaachen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This study on the clinical translation of the super-resolution ultrasound imaging technique

motion-model ultrasound localization microscopy (mULM) is composed of three parts. First, an

ultrasound scan protocol will be developed by providing patients with primary breast

carcinoma with an ultrasound scan to assess the size, location, and structure of the tumor.

Images in the form of B-mode ultrasound, elastography, and contrast ultrasound will be

obtained, and mini-movies of the CEUS examinations will be evaluated in a post-processing

step. There, individual microbubbles of the ultrasound contrast agent will be identified and

tracked to reconstruct the microvasculature of the tumor lesions. Participants will each

receive 2 different doses of the clinically approved ultrasound contrast agent SonoVue®. The

morphological and functional parameters obtained through the post-processing with the mULM

algorithm are then analyzed and subsequently validated with histological examinations.

Finally, the ultrasound examination protocol will be optimized and the corresponding dosage

of the ultrasound contrast agent determined.

The examination protocol established in the first section will subsequently be applied to

patients with primary breast carcinoma receiving neoadjuvant chemotherapy. Contrast-enhanced

ultrasonography will be performed at three time points during the chemotherapy cycles and

will be performed to assess tumor perfusion through application of the mULM-algorithm. The

dosage of contrast agent is based on the dosage found in the previous part of the study. The

CEUS examination is followed by the infusion of the chemotherapeutic agent. After completion

of neoadjuvant chemotherapy, surgical resection of the tumor and microscopic examination of

the tissue are performed according to guidelines.

In the final part of the study, patients with suspected breast tumor lesions are examined.

They will first receive non-contrast-enhanced diagnostic ultrasound (B-mode and

elastography). A contrast-enhanced ultrasound examination is performed on the largest lesion.

To further develop the mULM methodology, this is performed as both 2D and 3D acquisition. The

dosage of the contrast agent examination is again based on the optimal dosage found in the

first study part. This ultrasound procedure is followed by guideline-guided biopsy for

histologic clarification of the tumors, assessing dignity, hormone receptor as well as and

HER2/neu status, proliferation rate, and vessel density.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Relative blood volume (Time Frame - Study Part A & C: approximately 1 day before surgical removal of tumor):
Relative blood volume in % - describes the degree of vascularization - measured with mULM

2. Blood flow (Time Frame - Study Part A & C: approximately 1 day before surgical removal of tumor):
Blood flow in mm/s - measured with mULM

3. Change of relative blood volume (Time Frame - 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 relative blood volume in %

4. Change of blood flow (Time Frame - 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 in mm/s

Secondary outcome:

1. Change of tumor size (Time Frame - 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 tumor size determined based on ultrasound B-mode imaging

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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