- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02364388
IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) (MAESTRO)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Arnhem, Pays-Bas, 6815 AD
- Rijnstate Hospital
-
Dordrecht, Pays-Bas
- Albert Schweitzer Hospital Dordrecht
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Hengelo, Pays-Bas, 7555 DL
- Zorggroep Twente
-
Nijmegen, Pays-Bas, 6500 HB
- Radboud University Nijmegen Medical Centre
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Utrecht, Pays-Bas, 3508 GA
- University Medical Center Utrecht
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Imagio IUS gray-scale ultrasound
Imagio gray-scale ultrasound
|
Imagio diagnostic gray-scale ultrasound
Autres noms:
Diagnostic opto-acoustic +gray-scale ultrasound
Autres noms:
|
Autre: Imagio OA/US
Imagio OA/US (opto-acoustic+gray-scale ultrasound)
|
Imagio diagnostic gray-scale ultrasound
Autres noms:
Diagnostic opto-acoustic +gray-scale ultrasound
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses
Délai: 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.
|
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.
|
OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- MAESTRO-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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