Tag Archives: Clinical Trials

Case Study: Dominantly Inherited Alzheimers Network (DIAN) Trials Unit

“XNAT CR passed industry audits with flying colors.”
Tammie Benzinger, MD, PhD, Director of Imaging, DIAN Trials Unit @ Washington University School of Medicine

The Dominantly Inherited Alzheimer Network (DIAN) clinical trials unit is running phase II/III trials of drugs developed by Eli Lilly and Roche to assess their efficacy in treating early onset Alzheimer’ disease, using imaging endpoints.

DIAN imaging data is collected at clinical sites around the world – in North America, Australia, Europe and soon in Asia and South America – and uploaded to XNAT CR using the built-in web-based upload tool. This imaging data is then routed to quality control reviewers at sites around the country. Radiologics worked with Dr. Tammie Benzinger, DIAN Imaging Core Leader, to customize XNAT CR data types, workflows, pipelines and reports for the DIAN TU protocol.

“XNAT CR’s 21 CFR Part 11 compliance, along with its customizability, were key factors in selecting a data management system for the DIAN trials,” says Dr. Benzinger.

XNAT CR manages the full imaging workflow from acquisition to quality control to image processing and analysis. Dr. Benzinger reports, “XNAT’s workflow and notification system ensures that data are quickly uploaded, reviewed, and processed seamlessly.”

Case Study: Dementia Research Centre at University College London

“XNAT is at the center of all of our work.”
David Cash, PhD, Senior Research Associate at Dementia Research Centre, Institute of Neurology, University College London

The Dementia Research Center (DRC) at University College London is undertaking a wide range of research studies, clinical trials, data sharing programs, and software development projects.

“XNAT is at the center of all of work, whether it’s the MIRIAD program to publicly share Alzheimer’s disease imaging data or the Genetics Frontotemporal Dementia Initiative (GENFI) clinical trials”, says Dr. Cash.

The MIRIAD Database contains a total of 708 longitudinal MRI scans of 46 Alzheimers sufferers and 23 healthy elderly controls. Many scans were collected of each participant at intervals from 2 weeks to 2 years, the study was designed to investigate the feasibility of using MRI as an outcome measure for clinical trials of Alzheimer’s treatments.

Radiologics consulted on support for storing this longitudinal data, and on the technical setup for hosting a publicly shared dataset.

The GENFI project is a clinical trial study studying genetically-inherited Frontotemporal Dementia (FTD). The study is actively collecting data from 24 sites in 10 countries in Europe and North America.

Radiologics worked with the DRC to build a suite of case report forms to capture clinical and behavioral assessments in XNAT. According to Dr. Cash, these custom extensions have simplified his group’s program: “XNAT CR serves as a single source for capturing and analyzing all data collected in GENFI. We don’t need to validate and operate separate systems for imaging and clinical data.”