Tomosynthesis Mammographic Imaging Screening Trial

Titre officiel

Tomosynthesis Mammography Imaging Screening Trial Lead-in

Sommaire:

Un essai de dépistage aléatoire pour comparer l'exactitude diagnostique du dépistage du cancer du sein à l'aide de la tomosynthèse mammaire numérique (TMN) et de la mammographie numérique plein champ bidimensionnelle (MNPCB) comparativement à la MNPCB seule.

Description de l'essai

Primary Outcome:

• Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison

Secondary Outcome:

• Recall Rates
• Interval Cancers
• Prevalence of Breast Cancer Subtypes
• Clinical Characteristics of Cancers
• Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
• Biomarker Correlation

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) LEAD-IN is being conducted to ensure that all Eastern Cooperative Oncology Group / American College of Radiology Imaging Network (ECOG/ACRIN) TMIST components are properly functional and to provide an opportunity for fine tuning before launching the full TMIST. The accrual target for TMIST LEAD-IN is 6354 participants (one tenth of the projected enrollment target for TMIST) at three lead-in study sites: 1. Sunnybrook Health Sciences Centre in Toronto, 2. Vancouver (under the auspices of the Screening Mammography Programme of British Columbia) and 3. The Ottawa Hospital.

Voir cet essai sur ClinicalTrials.gov