IVMT is advancing its lead molecular imaging technology through clinical development for the evaluation of indeterminate biliary strictures, a challenging clinical problem in which distinguishing benign from malignant disease can be difficult.
Our lead imaging agent is a near-infrared fluorescent peptide heterodimer targeting EGFR and ErbB2 (HER2). The agent is designed for topical administration within the bile duct and visualization during cholangioscopy.
IVMT is advancing a multi-center Phase II clinical study designed to evaluate the safety and clinical performance of its targeted molecular imaging agent.
The study will evaluate whether near-infrared fluorescence imaging can provide additional molecular information during cholangioscopy and help distinguish malignant from benign indeterminate biliary strictures.
The study is planned across multiple academic medical centers, providing an opportunity to evaluate the technology across diverse clinical settings and patient populations.
Conventional evaluation of biliary strictures relies on anatomical visualization, tissue sampling, and pathological assessment. However, obtaining a definitive diagnosis can be challenging when initial findings are inconclusive.
IVMT's approach is designed to provide molecular information during the endoscopic procedure, complementing conventional anatomical imaging and biopsy.
By targeting molecular features associated with malignancy, IVMT aims to improve diagnostic confidence and support more informed clinical decision-making.
IVMT's clinical development program represents the translation of targeted molecular imaging from academic research into a clinically evaluated technology.
The program encompasses:
Target identification → Peptide ligand development → NIR fluorescent imaging agent → Endoscopic imaging → Clinical evaluation → Potential clinical application
Phase II | Multi-Center Clinical Development
Lead indication: Indeterminate biliary strictures
Imaging modality: Near-infrared fluorescence
Molecular targets: EGFR and ErbB2 (HER2)
Administration: Topical biliary administration
Procedure: Cholangioscopy
Development objective: Distinguish benign from malignant strictures