Allgemeine Informationen
  • Krankheitskategorie Brustkrebs (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Dr. Thomas Frauenfelder thomas.frauenfelder@usz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 07.03.2025 ICTRP: Import vom 17.01.2025
  • Letzte Aktualisierung 07.03.2025 07:36
HumRes63393 | SNCTP000005703 | BASEC2023-D0101 | NCT06291896

Clinical validation of a microwave-based medical device for breast cancer screening

  • Krankheitskategorie Brustkrebs (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Dr. Thomas Frauenfelder thomas.frauenfelder@usz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 07.03.2025 ICTRP: Import vom 17.01.2025
  • Letzte Aktualisierung 07.03.2025 07:36

Zusammenfassung der Studie

MammoWave® is a non-CE marked device that uses microwaves instead of ionizing radiation (X-rays). The aim of this clinical study is to investigate the performance of MammoWave® as a medical device and to determine whether it possesses the necessary characteristics to be used efficiently and safely in breast cancer screening. Patient participation lasts one day, and they are invited for an examination with MammoWave® after the standard mammography. The MammoWave® device is a bed with a plexiglass tray in which the patient's breast is placed. Patients lie face down and are examined for about 8 minutes per breast.

(BASEC)

Untersuchte Intervention

The results of the standard mammography are compared with those of the MammoWave® examination

(BASEC)

Untersuchte Krankheit(en)

Breast cancer screening

(BASEC)

Kriterien zur Teilnahme
-Women without symptoms of breast cancer aged between 45 and 74 years. -Signed informed consent prior to the start of study activities. -Average breast cancer risk (except for patients with known BRCA1 and 2 mutations and TP53 and/or previous breast cancer). (BASEC)

Ausschlusskriterien
-Women with breast implants. -Women with symptoms or signs of suspected breast cancer. -Women with known BRCA1, 2, TP53 or previous breast cancer. (BASEC)

Studienstandort

Zürich

(BASEC)

Italy, Poland, Portugal, Spain, Switzerland (ICTRP)

Sponsor

Umbria Bioenergeenering Technologies (UBT) srl

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Dr. Thomas Frauenfelder

+41442559383

thomas.frauenfelder@usz.ch

Diagnostische und Interventionelle Radiologie UniversitätsSpital Zürich Rämistrasse 100 8091 Zürich Schweiz

(BASEC)

Allgemeine Auskünfte

0039 3490564302

thomas.frauenfelder@usz.ch

(ICTRP)

Wissenschaftliche Auskünfte

0039 3490564302

thomas.frauenfelder@usz.ch

(ICTRP)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

07.06.2024

(BASEC)


ICTRP Studien-ID
NCT06291896 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly (BASEC)

Wissenschaftlicher Titel
A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave? in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly (ICTRP)

Öffentlicher Titel
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave? in a Population-based Screening Program for Early Breast Cancer Detection (ICTRP)

Untersuchte Krankheit(en)
Women's Health: Neoplasm of Breast (ICTRP)

Untersuchte Intervention
Device: MammoWave (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Gender: Female
Maximum age: 74 Years
Minimum age: 45 Years
Inclusion Criteria:

- Women aged between 45 and 74 years

- Asymptomatic

- Signed informed consent form before starting any study activity

- Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or
previous BC)

- Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT)
(collecting oblique mediolateral projection [MLO] of the right breast, craniocaudal
projection [CC] of the right breast, MLO projection of the left breast, CC
projection of the left breast), performed within the past month with available
results or planned to be performed in the same day of the MammoWave test or in the
subsequent days

- Spontaneous willingness to comply with CIP and recommendations

Exclusion Criteria:

- Woman with breast prostheses

- Women with symptoms or some sign of suspected BC

- Women with BRCA1, 2, TP53 or previous BC

- Pregnant women

- Women who do not have mammographic manifestation of the tumor (known occult breast
tumor with only axillar manifestation)

- Women with breast size larger than the largest MammoWave cup size (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
MammoWave? sensitivity;MammoWave? specificity (ICTRP)

Detection rates by type of lesion;Recall rate;Positive-predictive value;Program screening rate;BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density;MammoWave? sensitivity and specificity after retrospective AI adjustment using the data at the end of the study;Agreement between different evaluator (i.e. local versus central);Volunteers' satisfaction questionnaire (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
London South Bank University;ELAROS 24/7 Limited (UK);Servicio De Salud De Castilla La Mancha (Spain);IMT School for Advanced Studies Lucca;EVITA - Cancro Heredit?rio (Portugal);Fondazione Toscana Life Sciences (Italy) (ICTRP)

Weitere Kontakte
Gianluigi Tiberi, gianluigi@ubt-tech.com, 0039 3490564302 (ICTRP)

Sekundäre IDs
UBT 2023-01 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06291896 (ICTRP)

Ergebnisse der Studie

Zusammenfassung der Ergebnisse

nicht verfügbar

Link zu den Ergebnissen im Primärregister

nicht verfügbar