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Leaders in Quality Assurance for Radiation Therapy Clinical Trials

IROC Philadelphia Radiation Therapy has over 40 years of experience in the quality assurance (QA) of radiotherapy (RT) and related imaging for international multi-center clinical trials. Our services incorporate processes that extend through the lifetime of a clinical trial, from the initial stages of protocol development to the protocol's activation, data transfer (including quality control), and data analysis. Each step is optimized to the trial and automated for accuracy and efficiency. Our team has quality assurance technical expertise and interpersonal experience from collaborating with clinical trial researchers and associates globally.

CORE SERVICES Offered by IROC Philadelphia Radiation Therapy

Trial Design Support

With over 40 years of experience, our group can offer expertise to help in the development of new protocols that utilize radiotherapy.  

Medical Physics support is provided from the University of Pennsylvania. We work with the Radiation Oncologist PI in the development of the RT section of the protocol. We have developed standardized protocol templates for the radiation therapy section to provide a framework that allows for consistency and uniformity in order to adhere to radiation oncology standards.

We join forces with the center for innovation in radiation oncology of NRG Oncology (CIRO) to develop templates for various disease sites, as well as for radiopharmaceutical therapy, as available from the following site.

https://www.nrgoncology.org/About-Us/Center-for-Innovation-in-Radiation-Oncology

Radiation Therapy (RT) Data Management

Our team has years of experience with Medidata Rave; our detailed review and verification ensure the accuracy of site responses on RT forms designed for electronic data capture. We ensure our eCRF’s are CDISC/CDASH compliant.

DICOM RT Plan

Digital DICOM RT Plan Data Submission is performed with the TRIAD platform. The TRIAD is the image acquisition and management software, Transmission of Imaging and Data (TRIAD), managed by the American College of Radiology.  TRIAD offers a web-based software solution allowing institutions to submit DICOM data securely through electronic transmission.  Internal to the site, TRIAD allows the site to "DICOM push" from the site's Treatment Planning System (TPS), thus eliminating the need to burn physical media.   Upon submission, the software will anonymize, encrypt, and submit the DICOM RT data securely. TRIAD NCI Oncology Domain utilizes your CTEP IAM username and password to gain access.

https://www.irocqa.org/Resources/TRIAD

Digital Data Submission Information (DDSI)form

Upon submission of the RT plan via TRIAD sites, a web-based form is offered to provide pertinent information on the plan and to trigger an alert on a Pre-treatment case.  CTEP-IAM username and password is utilized to login to the DDSI form

https://cr-rtqa-web.acr.org/Home/CTEPLOGIN

RT Case Review

We use state of the art software to evaluate and analyze RT data and our reviewing Radiation Oncologists are provided convenient and secure access to review treatment plans remotely.  The Diagnostic Imaging used for planning is also collected and fused with the RT plan to ensure the highest accuracy in the dosimetric review process. We are also experienced in reviewing radiation treatment charts in a range of formats, which provides the team with a comprehensive overview of the radiotherapy process from start to finish.

Our team of Dosimetrists is trained and knowledgeable in the assessment and review of DICOM RT plans for protocol compliance. Protocol specific Dose Volume Analysis reviews are completed and provided to the reviewing Radiation Oncologist by our staff. This is reviewed and scored by the Radiation Oncologist, along with the contour evaluation they complete.

Real-time Pre-Treatment reviews can be performed, and feedback provided to the enrolling site within 72 business hours of receipt of the required data. This option ensures a higher compliance rate, as feedback is provided to the site prior to administering any RT. The site can make any necessary changes and resubmit the data for another review.

For those cases appropriate for post-treatment review, feedback can be provided to the sites as a reference for planning future enrolled cases. This valuable educational tool also aids in significantly lowering the deviation rate.

Digital Data Integrity Quality Assurance (DDIQA)

Prior to completing the submission in TRIAD, the person submitting the data can review the validation profile for structure naming compliance.

Once the submission is complete, IROC will review the submission for completeness and, if needed, query the site staff listed on the DDSI form to correct and resubmit.

Case Review

Our Dosimetry staff reviews the RT plan in state-of-the-art software. A Dose Volume Analysis is performed to verify compliance with the protocol and then prepared for review by a radiation oncologist who specializes in that disease site. Feedback is provided to the site, and completed forms are provided to LPO/ Sponsor.

Knowledge-based case review with machine learning models

https://www.nrgoncology.org/About-Us/Center-for-Innovation-in-Radiation-Oncology

https://www.xrt.upenn.edu/xrt/XiaoLab/#

Structure Standardization and Review, Assisted by AI

https://www.nrgoncology.org/About-Us/Center-for-Innovation-in-Radiation-Oncology

                   https://www.xrt.upenn.edu/xrt/XiaoLab/#

RPT Dosimetry

In radiopharmaceutical therapy (RPT), a radionuclide is systemically or locally delivered with the goal of targeting and delivering radiation to cancer cells while minimizing radiation exposure to untargeted cells. Assessment of radiation doses in individual patients and their correlation with tumor and normal tissue response to radiation is essential for analyzing the outcome of clinical trials combining RPT with new chemotherapeutic agents. Thus, we aimed to provide dosimetry evaluation as well as quality assurance for the RPT voxel-level dosimetry. As there can be inter-lesion and inter-patient heterogeneity in radionuclide intake, dosimetry will help to measure the absorbed dose in each voxel throughout the body. Dosimetry will also measure biodistribution, especially in critical organs for toxicity. We work with experts in the field of RPT voxel dosimetry and provide protocol templates (https://www.nrgoncology.org/About-Us/Center-for-Innovation-in-Radiation-Oncology/Radiopharmaceutical-Therapy), quality assurances for imaging and processes and perform voxel-level dosimetry calculations and evaluations.

Quality Assurance Research

https://www.xrt.upenn.edu/xrt/XiaoLab/#

NCTN Medical Physics Collaboration

IROC Philadelphia has created for the NCI Program Director in Medical Physics an informal, National Clinical Trials Network (NCTN)-wide Physics committee as a forum for the exchange of ideas and best practices among the NCTN groups and to advise IROC.

IROC Philadelphia manages virtual meetings that facilitate the interaction of Radiation Oncology Physicists with the NCTN and the NCI. Discussion on the portfolio of grants that includes all aspects of clinical physics in radiation oncology, novel medical devices, new treatment modalities such as ion beam therapy, on-line imaging techniques, as well as the emerging fields of AI applications in radiotherapy, Big Data analytics, and machine learning. This information is shared with the NCTN medical physics liaisons from the various clinical trial groups comprising the National Clinical Trials Network (NCTN) – Alliance, ECOG-ACRIN, NRG Oncology, SWOG, Children’s Oncology Group COG), and Canadian Cancer Trials Group (CCTG).

IROC Philadelphia works with the NCI Program Director in Medical Physics and the IROC QA Director from Philadelphia to coordinate the physics-related activities of the Radiation Research Program with other programs within NCI, NIH, and other Federal agencies;

IROC Philadelphia provides a focal point within NCI for extramural investigators engaged in technological activities that relate to radiation oncology and who might benefit from scientific and technical interactions with Radiation Oncology Physicists within the NCTN.

Contacts

IROC Philadelphia

50 South 16^th Street Suite 2800

Philadelphia, PA 19102

215-574-3219 or 800-227-5463, extension 4219