Brief description of trial (Data source: BASEC)
Wir wollen für die Behandlung von einzelnen Tumorknoten in der Brust untersuchen, ob/ wie gut das Medizinprodukt Philips Sonalleve MR-HIFU wirksam/verträglich/sicher ist und ob die Nachbeobachtung der Behandlung mit MRI zum gleichen Ergebnis kommt wie die Nachuntersuchung des behandelten Tumorknotens in der Histologie.
Health conditions investigated(Data source: BASEC)
Behandlung von einzelnen Tumorknoten in der Brust
Health conditions
(Data source: WHO)
Breast Cancer, Invasive Ductal
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Das Gerät kann ohne Verletzung der Haut mit gebündeltem Ultraschall direkt das bösartige Tumorgewebe erhitzen und so vernichten. Diese Brennpunkte können millimetergenau im ganzen Tumor platziert werden. Das umliegende gesunde Gewebe kann geschont werden.
Interventions
(Data source: WHO)
Device: Philips Sonalleve® MR-HIFU Breast Therapy System
Criteria for participation in trial
(Data source: BASEC)
Es können alle Patientinnen teilnehmen, bei denen vor kurzem ein Tumor in der Brust gefunden wurde, der chirurgisch entfernt werden soll. Sie müssen mindestens 18 Jahre alt sein. Ihr Gesundheitszustand und Ihre medizinische Eignung für diese Studie werden von den Studienärzten vorab überprüft.
Exclusion criteria
(Data source: BASEC)
Nicht teilnehmen dürfen Personen, bei denen bereits eine Tumorbehandlung an der betroffenen Brust durchgeführt wurde. Patientinnen, die für den Eingriff nicht auf dem Bauch gelagert werden können und schwangere oder stillende Frauen können ebenfalls nicht an der Studie teilnehmen.
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Informed Consent as documented by signature
- World Health Organization (WHO) performance status= 2
- Body weight = 80 kg
- Biopsy proven invasive breast cancer with a size of =3.0cm (TNM classification: cT1-2
N0-2 MX ).
- Histological type of tumor: invasive ductal carcinoma (IDC)
- Patient is scheduled for surgical resection of tumor at study site
- Tumor location within the reach of the HIFU transducers with the patient in prone
position; distance from skin and pectoral muscle to the tumor = 1.0 cm.
- Target breast fits in the cup of the dedicated MR-HIFU breast system
Exclusion Criteria:
- neoadjuvant systemic therapy
- prior radiotherapy in target breast
- contraindications for MRI
- contraindication for application of gadolinium-based contrast agent
- contraindication for procedural sedation analgesia
- macro-calcifications in or around the targeted tumor
- scar tissue or surgical clips in the direct path of the ultrasound beams
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases.
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug/device within the 30 days
preceding and during the present study,
- Previous enrolment into the current study
-
Further information on trial
Date trial registered
May 14, 2018
Incorporation of the first participant
Jan 13, 2020
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Accuracy of MRI as method for assessment of quantitative treatment success (correlation with results of the histopathological analysis performed as reference method);Accuracy of MRI as method for assessment of qualitative treatment success (correlation with results of the histopathological analysis performed as reference method)
Secundary end point
(Data source: WHO)
Assessment of treatment efficacy
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Winterthur
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Christoph Binkert
+41 052 266 26 02
christoph.binkert@ksw.ch
Contact for general information
(Data source: WHO)
Christoph A Binkert, MD
Kantonsspital Winterthur KSW
+41 52 266 2602;+41 52 266 26 02
christoph.binkert@ksw.ch
Contact for scientific information
(Data source: WHO)
Christoph A Binkert, MD
Kantonsspital Winterthur KSW
+41 52 266 2602;+41 52 266 26 02
christoph.binkert@ksw.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
03.01.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-01282
Secondary ID (Data source: WHO)
2017-MD-0021
2017-01282 (BASEC)
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