Abstract
Transmission of Imaging and Data (TRIAD) is a standard-based system built by the American College of Radiology (ACR) to provide seamless exchange of images and data for accreditation of clinical trials and registries. Scripts of structures’ names validation profiles created in TRIAD are used in the automated submission process. It is essential for users to understand the logistics of these scripts for successful submission of radiotherapy cases with less iteration.
Logistics of Structures’ Validation Profiles in TRIAD
Imaging and Radiation Oncology Core (IROC) has been formed to provide quality assurance (QA), along with clinical and scientific expertise, for the entire National Clinical Trials Network (NCTN)[1]. As part of the IROC clouds (an integrated information technology (IT) infrastructure) [2], Transmission of Imaging and Data (TRIAD) is a standard-based system built by the American College of Radiology (ACR) to provide seamless exchange of images and data for accreditation of clinical trials and registries [3]. NRG Oncology Center of Innovation in Radiation Oncology (CIRO) and IROC jointly developed a new library for structures names [2] to be used in NRG Oncology clinical trials. It is of utmost importance to standardize structure names in multi-center clinical trials for quality conduct of the trial, quality of trial data and accessibility of data for analysis beyond trial. The radiotherapy section of any of NRG Oncology clinical trial includes a list of required structures (target volumes and organs at risk) to be contoured and must be submitted to the QA center for each patient to be treated using these trials. Scripts of structures’ names validation profiles created in TRIAD are used in the automated process. It is essential for users to understand the logistics and design of these scripts for successful implementation of the standardization and for successful submission of radiotherapy cases with less iteration. TRIAD currently supports different layers of filters and rules and allows the definition of one layer or multiple layers depending on the complexity of the clinical trials. Upon submission of digital data in TRIAD, the user can be prompted to select the layer that applies to the data to be submitted. Users are able to see which structure(s) is (are) missing from within the TRIAD submission window prior to sending the data for Validation profiles. TRIAD allows the administrator to apply “hard” or “soft stop” to the validation. If a hard stop is applied, the user cannot proceed with submission if any of the list structures or validation parameters are missing, misspelled, or do not meet the defined protocol criteria. Here, the user must adjust the structures (number of structures and their correct names) list according to the clinical trial. However, when a soft stop is applied, even a failed validation allows users to proceed with submission.
Description of TRIAD Structures’ Validation Profile
TRIAD (latest version -4.4) currently supports multiple layers of filters and rules. Filters are criteria which allow for the inclusion or exclusion of submissions for the application of rules, whereas the rules themselves judge the submission for protocol adherence for which they are applied. The filters can be defined as All and Any; All means that all of the assigned filter criteria must be met while Any means that any of the assigned filter criteria can be met for TRIAD to apply the validation rule or set of rules to the series. The validation profile of a clinical trial that includes only one arm usually consists of one layer which includes all required structures for submission. However, multiple layers can be defined for clinical trials that include more than one arm or if some of the structures are only required for submission when they are applicable. Table 1 lists three examples for structures’ validation profiles for NRG CC001, RTOG 1216 and RTOG 0815 clinical trials respectively to demonstrate the different possibilities of building these profiles, depending on the complexity of the clinical trial. The validation profile for NRG CC001 clinical trial is an example of a simple validation profile, which consists of one layer only. Here, all target volumes and critical structures listed in the protocol must be submitted. The structure validation profile for RTOG1216 clinical trial is an example of a validation profile when some structures must be submitted and some other structures are only required for submission if the situation is applicable. Here, the profile has sub layers. The first layer of the profile requires the submission of all defined structures. The other sub layers are only applicable if the clinical situation exists as defined in the protocol (for example PTV_5600). The purpose of including these sub layers is to remind the user of what should be submitted, if the clinical situation calls.
Table 1.
Examples of Structure’ Validation Profiles in TRIAD.
| Trial number and name |
Validation profiles | Rule | Content |
|---|---|---|---|
| NRG-CC001: A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases | One validation profile | All | CTV_3000|PTV_3000|Hippocampi|Hippocampi_05|Hippo_L|Hippo_R|Lens_L|Lens_R|OpticNerve_L|OpticNerve_R|OpticChiasm. |
| RTOG 1216: Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck | All required structures | All | CTV_6000|PTV_6000|NonPTV_6000|SpinalCord|SpinalCord_05|BrainStem|BrainStem_03|Lips|OralCavity|Parotid_R|Parotid_L|Pharynx|Esophagus_Up|LarynxGSL|Mandible|External|NonPTV |
| 5600 if applicable | All | CTV_5600|PTV_5600 | |
| 6600 if applicable | All | CTV_6600|PTV_6600 | |
| Evals if applicable | Any | PTV_5600_Eval|PTV_6000_Eval|PTV_6600_Eval | |
| RTOG0815: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk | Arm1/Arm 2 initial/EBRT boost | All | GTV|CTV|PTV|Bladder|Femur_L|Femur_R|PenileBulb|Rectum|External|SeminalVesicle |
| ARM1/ARM2 HDR Brachy boost | All | SeminalVesicle|CTV|PTV|Prostate|Urethra|Rectum|Bladder | |
| Prostate Cancer | Arm1/Arm2 LDR Brachy boost | All | ETV|Bladder|Rectum |
Conclusions
Submitting institutions are encouraged to be aware of the required structures for submission for each trial to avoid possible delay in submission of DICOM data as hard stop and soft stops are planned for implementation. The implementation of these validation profiles and the ability to view the results at the time of submission will also provide valuable initial feedback to the submitting site and eventually improve the efficiency of clinical trials data submissions.
Acknowledgments
This project was supported by NCI grants U24CA180803, U10CA180868, and PA CURE grant.
Footnotes
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Disclosure: Nothing to disclose
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