The role of imaging in the clinical development of antiangiogenic agents
Bruno Morgan1, Mark A Horsfield, William P Steward
1Department of Cancer and Molecular Medicine, University of Leicester, Leicester Royal Infirmary, Leicester LE1 5WW, UK. bruno.morgan@uhl-tr.nhs.uk
Abstract:
Early clinical development of novel antiangiogenesis agents is hampered by the fact that classic response end points are unlikely to be relevant and there is a lack of validated surrogate markers of efficacy. Toxicity-based decisions for dose setting and tumor size measurements by standard imaging probably are not be applicable. Because these agents modify a multitude of biologic processes that may cause early measurable effects, there is great interest in developing imaging tests that are sensitive to changes in tissue function. This article discusses the development of such "functional" clinical imaging and attempts to address the questions that are being asked of imaging departments by oncologists and pharmaceutical companies.
Insights
Developing new antiangiogenesis drugs faces challenges with traditional efficacy measures. Functional imaging offers a promising solution by detecting early biological changes, aiding dose selection and treatment assessment.
Area of Science:
- Oncology
- Medical Imaging
- Pharmacology
Background:
- Early clinical trials for novel antiangiogenesis agents face significant hurdles.
- Traditional efficacy endpoints and surrogate markers for these agents are often inadequate.
- Standard imaging techniques and toxicity-based dose-setting may not be suitable for novel antiangiogenesis therapies.
Purpose of the Study:
- To explore the development of functional clinical imaging techniques.
- To address the need for sensitive imaging biomarkers in antiangiogenesis drug development.
- To provide guidance for imaging departments supporting oncologists and pharmaceutical companies.
Main Methods:
- Discussion of the development of "functional" clinical imaging.
- Focus on imaging tests sensitive to changes in tissue function.
- Addressing the specific questions posed by oncologists and pharmaceutical companies regarding imaging in early drug development.
Main Results:
- Functional imaging holds potential for early detection of treatment effects.
- Development of novel imaging approaches is crucial for antiangiogenesis drug evaluation.
- Identifying sensitive imaging biomarkers can overcome limitations of traditional endpoints.
Conclusions:
- Functional imaging is essential for the successful early clinical development of antiangiogenesis agents.
- Validated surrogate markers and functional imaging techniques are needed to assess efficacy.
- Collaboration between imaging specialists, oncologists, and pharmaceutical companies is key to advancing this field.
