Phase I/II Biologic Trial in Metastatic Colorectal Cancer With Unresectable Liver Metastases

Challenge

A multicenter Phase I/II trial evaluated a novel investigational biologic in patients with unresectable colorectal liver metastases. Early-phase trials generate decisions about dose and expansion from small numbers of patients, so each response assessment carried significant weight, and liver metastases imaged with CT and MRI present measurement challenges from contrast phase, lesion conspicuity and treatment-related changes in lesion appearance.

The sponsor needed consistent response assessment under RECIST 1.1 with sensitivity to liver-specific changes such as necrosis and reduced enhancement, and a fast turnaround so that imaging results could inform dose-escalation and cohort decisions.

Intrinsic Imaging’s Solution

Intrinsic Imaging processed all study images centrally, with quality control confirming contrast phase and liver coverage at receipt. Acquisition guidance addressed portal venous phase timing for CT and hepatobiliary-phase sequences where MRI was used, and sites were supported to keep each patient on a consistent modality.

Oncology radiologists experienced in hepatic malignancy performed blinded reads under RECIST 1.1, with the charter additionally capturing lesion enhancement and necrosis so that the sponsor could evaluate biologic activity beyond size-based response. Discordant reads were adjudicated.

Read turnaround was prioritized to support cohort decision timelines, and results were delivered in a structure suitable for both the Phase I safety review and the Phase II efficacy analysis.

Intrinsic Imaging’s Results

• Approximately 85 patients at 9 sites assessed with blinded RECIST 1.1 reads and liver-specific enhancement and necrosis capture
• Median read turnaround of three business days to support dose-escalation and cohort-expansion decisions
• Contrast phase and liver coverage verified at central quality control for every timepoint before reader access
• Response dataset delivered in a structure serving both Phase I safety review and Phase II efficacy analysis