International Phase III Severe Traumatic Brain Injury Trial Across 100+ Sites

Challenge

A large international Phase III trial of a treatment for severe traumatic brain injury enrolled more than 1,000 patients across more than 100 investigator sites. Imaging was acquired in emergency settings on whatever scanner was available, often at night, and the endpoint depended on neuroradiological assessment of the progression of intracranial pathology including contusion expansion, hematoma volume, edema and midline shift.

The sponsor needed standardized reading of highly heterogeneous acute imaging, volumetric measurement of hemorrhagic lesions that is sensitive to window settings and slice thickness, and a team large enough to handle a continuous, time-critical volume from more than 100 sites.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the imaging charter around a pragmatic acute head CT protocol achievable in emergency settings, with minimum requirements for slice thickness and reconstruction, and trained sites to submit serial imaging within defined windows. Image acquisition, transfer and quality control were centralized with 24-hour receipt confirmation.

A dedicated team of eight board-certified neuroradiologists performed blinded reads under a charter that defined hemorrhage classification, volumetric measurement methods, midline shift measurement and progression criteria. Primary progression assessments were double-read with adjudication.

Reader calibration used reference cases spanning the range of traumatic pathology, and agreement was monitored at planned intervals across the trial. Project managers maintained the imaging schedule for more than 1,000 patients and chased missing serial scans with sites.

Intrinsic Imaging’s Results

• Imaging from more than 1,000 patients at more than 100 international sites processed and read by a dedicated eight-neuroradiologist team
• Hemorrhage volumetry and midline shift measured under fixed conventions with reader agreement on progression above 88%
• Unevaluable acute examinations held under 6% despite emergency-setting acquisition through pragmatic protocol design and site feedback
• Serial imaging completeness above 90% through active tracking of protocol-defined imaging windows