Four-Year Multinational Phase II Metastatic Breast Cancer Trial Across 60 Sites

Challenge

A four-year multinational Phase II trial in metastatic breast cancer spanned more than 60 investigator sites in 10 countries. Over that duration and geography, the sponsor faced the operational risks of inconsistent acquisition, delayed image transfer and variable site interpretation of RECIST, any of which could compromise the response dataset.

The sponsor required a core lab to manage acquisition, transfer and processing across all sites and to provide oncology-subspecialized radiologists for guidance on RECIST interpretation, keeping the trial's imaging consistent and on schedule.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed acquisition guidelines for CT, MRI and bone scintigraphy, qualified and trained the 60-plus sites in their local languages where needed, and established centralized image transfer with receipt confirmation and quality control at every timepoint.

Oncology-subspecialized radiologists provided RECIST interpretation guidance under a charter defining target lesion selection, handling of bone and non-target disease and progression confirmation, and reviewed examinations where site assessments raised queries or where the protocol required central confirmation.

Project management maintained the imaging schedule across four years, tracked site compliance by country and escalated recurring acquisition issues, with periodic reader calibration to maintain consistency across the trial.

Intrinsic Imaging’s Results

• Imaging from more than 60 sites in 10 countries acquired, transferred and processed centrally over four years
• Approximately 3,200 timepoints quality-controlled with acquisition deviations returned to sites within two business days
• RECIST interpretation guidance and central confirmation delivered under a single charter across all countries
• Timepoint completeness above 92% through active schedule tracking across the four-year duration