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Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection
Willemieke S Tummers1, Jason M Warram2, Kiranya E Tipirneni3
1Department of Radiology, Molecular Imaging Program, Stanford University, Stanford, California.
Abstract:
Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process. This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. Cancer Res; 77(9); 2197-206. ©2017 AACR.
Insights
Standardizing optical imaging tools and contrast agents is crucial for faster FDA approval of cancer surgery navigation. This meeting focused on consensus methods for human testing and approval of these novel devices and drugs.
Area of Science:
- Oncology
- Medical Imaging
- Surgical Navigation
Background:
- Optical imaging advances enhance tumor resection precision.
- Real-time feedback from optical imaging aids surgeons.
- Standardization is needed for regulatory approval of optical surgical tools.
Purpose of the Study:
- Discuss consensus methods for FDA approval of optical imaging devices and contrast agents.
- Clarify FDA approval requirements for drugs and devices in optical surgical navigation.
- Provide guidance on data collection and trial design for researchers.
Main Methods:
- A one-day meeting convened experts from NCI, FDA, and professional societies.
- Discussions focused on FDA-directed human testing and approval pathways.
- Consensus methods for investigational optical imaging agents were deliberated.
Main Results:
- Recommendations for FDA approval of optical imaging devices and contrast agents were established.
- Clarity was provided on regulatory expectations for combined or separate drug/device development.
- Guidance on trial design and data collection for optical surgical navigation research was outlined.
Conclusions:
- Standardized approaches are essential for efficient regulatory approval of optical surgical navigation technologies.
- Collaboration between researchers and regulatory bodies will accelerate clinical adoption.
- The meeting provided a framework for developing and approving novel optical imaging agents for cancer surgery.
