Breast Cancer Trial With 3,000 Multimodality Breast Imaging Reviews

Challenge

A clinical trial evaluating the safety and effectiveness of a new breast cancer product required nearly 3,000 central reviews of breast imaging. Breast imaging assessment is multimodal and interpretive: lesion detection and BI-RADS categorization on mammography, ultrasound and MRI vary between readers, and the product's effectiveness depended on consistent lesion-level assessment across modalities and timepoints.

The sponsor needed fellowship-trained breast imagers reading to a fixed standard, lesion-level correlation across modalities, and management of a sizeable review volume from two locations without variation in reading convention.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the imaging charter with acquisition standards for full-field digital mammography, breast ultrasound and breast MRI, and lesion-level case report forms capturing location, size, morphology and BI-RADS assessment. Sites were qualified and trained on submission of complete multimodal examinations.

Breast imaging radiologists performed blinded reads under the charter, with lesion correlation across modalities governed by defined location-matching rules and with independent double reads on primary endpoint assessments. Discordant lesion detection or BI-RADS categorization was adjudicated.

The trial was managed from the Bolton and San Antonio locations under a single quality system, with centralized image transfer, quality control and processing and periodic reader calibration across both locations.

Intrinsic Imaging’s Results

• Nearly 3,000 breast imaging reviews completed across mammography, ultrasound and MRI by fellowship-trained breast imagers
• Lesion-level cross-modality correlation applied under defined matching rules for approximately 1,100 lesions
• Reader agreement on BI-RADS category within one level above 92% on primary endpoint assessments
• Single quality system and reading convention maintained across the Bolton and San Antonio locations throughout the trial