IHERO 2007UseCase Clinical Trials Submission

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Proposed Clinical Trial Use Case

This Use Case has been superceded by the Anonymization and the Structure Template Creation, Import, and Export use cases.

Charles M. Able, MS AAPM Work Group on Clinical Trials Liaison to IHE –RO Planning Committee September 18, 2006

The proposed use case would provide a structure for the digital transmission and resulting evaluation of protocol cases for clinical trial groups submitted to the quality assurance centers. Its purpose would be to facilitate uniformity of data submission irrespective of the treatment planning system used to generate the planning data.

A new approach should be taken where the QA centers develop a list of naming conventions for the RT Structure Set (GTV, CTV, PTV, Organs At Risk Volumes, Planning Organs At Risk Volumes, and Unspecified Tissue) which would be protocol specific and would be a subset of a “global” list that can be developed. This would be provided to the institution in the form of a DICOM RT structure set file (or other suitable format) with the structure names but without contours. The institution would then go through the list of structures and contour those applicable to the case and delete those that are not. Additional structures that are not called out in the protocol could be added by looking up the name in the clinical trials global list. The presence of the clinical trials global list is a new element for the TPS to adopt.

The information supplied to the QA center in the DICOM RT plan file (or other suitable container) should also include:

1. Localization and Immobilization Technique (patient and tumor) 2. Treatment history, ie. Dates treated, fields treated, daily dose, MUs, etc.

The Advanced Technology Consortium (ATC) can provide additional details of data formatting and other specific RT objects required but not listed above.

The IHE-RO Planning Committee should consider a use case which can help infuse structure and consistency in the format and process of data submission to clinical trial groups. This certainly has the potential to greatly increase the accrual rate of national clinical trials.

The adoption of this use case would provide a powerful tool to advance the collection and evaluation of clinical trials in radiation oncology.