KVUS at Neoadjuvant CTx of Breast Cancer

NCT03385200 | Unknown Phase 3

• 1 other identifier: 16-134
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy

Conditions

Early Primary Breast Cancer

Keywords

breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles

Outcome Measures

Primary Outcomes (3)

• Tumor size reduction (1)

  pCR (pathohistological complete remission)

  18 / 24 weeks

• Tumor size reduction (2)

  cCR (clinical complete remission)

  18 / 24 weeks

• Tumor size reduction (3)

  measured by ultrasound (% reduction in therapy)

  18 / 24 weeks

Secondary Outcomes (5)

• proliferation rate of the tumor cells

  18 / 24 weeks

• narrowing the invasion front of the tumors

  18 / 24 weeks

• macrophage density in the tumor

  18 / 24 weeks

• vascularization of the tumor

  18 / 24 weeks

• tolerability of chemotherapy

  18 / 24 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound

Drug: SonoVue

B

NO INTERVENTION

Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound

Interventions

SonoVue DRUG

As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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
• treatment with neoadjuvant chemotherapy
• persons who are legally competent and mentally able to follow the instructions of the study team

You may not qualify if:

• hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
• right-left shunt,
• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Univ.-Prof. Dr. med. F. Kiessling: collaborator

Study Sites (1)

Department of Gynecology and Obstetrics

Aachen, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

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

Study Officials

• Elmar Stickeler, niv.-Prof. Dr. med.

  Department of Gynecology and Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elmar Stickeler, Univ.-Prof. Dr. med.

CONTACT

+49 241 80 88400; estickeler@ukaachen.de

Fabian Kiessling, Univ.-Prof. Dr. med.

CONTACT

+49 241 80 80116; fkiessling@ukaachen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Model Details: Parellel Assignment

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 28, 2017
• Study Start: December 12, 2016
• Primary Completion: June 12, 2019
• Study Completion: December 12, 2019
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

DE (1)