IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) (MAESTRO)
24. marts 2020 opdateret af: Seno Medical Instruments Inc.
Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations.
This is a post-market, non-randomized multi-center surveillance study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a post-market surveillance study that is prospective, controlled, multi-center, to evaluate if Imagio OA can downgrade BI-RADS ( Breast Imaging-Reporting and Data System) classification following CDU (Conventional Diagnostic Ultrasound) for the visualization and characterization of suspicious masses prior to core needle biopsy (CNB) or excision.
Investigators will perform CDU to reach a diagnosis and decision to biopsy.
Imagio OA will not be used as the reason to perform or to defer a CNB (Core Needle Biopsy) or excision.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
217
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Arnhem, Holland, 6815 AD
- Rijnstate Hospital
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Dordrecht, Holland
- Albert Schweitzer Hospital Dordrecht
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Hengelo, Holland, 7555 DL
- Zorggroep Twente
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Nijmegen, Holland, 6500 HB
- Radboud University Nijmegen Medical Centre
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Utrecht, Holland, 3508 GA
- University Medical Center Utrecht
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria
- Female
- 18 years of age or older
- Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan
Exclusion Criteria:
- Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)
- Pregnant or lactating
- Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Imagio IUS gray-scale ultrasound
Imagio gray-scale ultrasound
|
Imagio diagnostic gray-scale ultrasound
Andre navne:
Diagnostic opto-acoustic +gray-scale ultrasound
Andre navne:
|
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Andet: Imagio OA/US
Imagio OA/US (opto-acoustic+gray-scale ultrasound)
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Imagio diagnostic gray-scale ultrasound
Andre navne:
Diagnostic opto-acoustic +gray-scale ultrasound
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses
Tidsramme: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.
|
Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3).
BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology.
BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy.
A BI-RADS score of 4 or more indicates the need for biopsy.
Specificity is reported with a 96% confidence interval using a normal approximation.
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CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.
|
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OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses
Tidsramme: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.
|
Outcome is the percentage of malignant masses correctly identified by (OA/US) ultrasonography as BI-RADS 4a or higher.
BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology.
BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy.
A BI-RADS score of 4 or more indicates the need for biopsy.
Sensitivity is reported with a 96% confidence interval using a normal approximation.
|
CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. marts 2015
Primær færdiggørelse (Faktiske)
15. februar 2016
Studieafslutning (Faktiske)
15. februar 2016
Datoer for studieregistrering
Først indsendt
10. februar 2015
Først indsendt, der opfyldte QC-kriterier
10. februar 2015
Først opslået (Skøn)
18. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. april 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- MAESTRO-01
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