Imaging Site Registry
Imaging Sites Registered: 233
US: 180
Europe: 28
Other: 25
A key to successful and timely implementation of a multicenter clinical trial using a centralized IND is speedy identification and qualification of imaging centers that are appropriately equipped and staffed to effectively execute the protocol defined in the IND. The SNM is currently developing an extensive, searchable database that will provide drug trial sponsors with the following:
- Contact information of qualified imaging centers and local PET biomarker manufacturers who have communicated a general desire to participate in trials work.
- A list of imagers and manufacturers who have appropriate capabilities to participate in a specific trial that is being organized by a drug trial sponsor.
- Qualified imaging centers, as determined by successful participation in ongoing assessment, monitoring, and certification programs to maintain imaging quality and standardization across Network imaging sites.
According to the FDA, in the past they have struggled with inconsistent imaging methods at different centers, making it very difficult to assess results in multicenter trials that include imaging data. To help address this challenge, the Network has developed a PET phantom program that will help all registered sites in the Network to demonstrate current standard imaging capabilities, including state of technology, staff training, and ability to adhere to standardized methods. Registry participation will require ongoing certification of qualifications.
Over 200 Molecular Imaging sites from around the world have registered already. If your imaging center has molecular imaging capabilities but has not already submitted your facility's name to the Network, please consider registering immediately.
There is no fee to register for the Network's Imaging Site Registry.
The Clinical Trials Network received approval for the first centralized IND in September, 2008. The IND application is for F-18-Fluorothymidine(FLT). Several pharmaceutical developers have expressed interest in utilizing this approved IND in near term clinical trial work. Active clinical trials utilizing FLT are expected to begin in 2010. Imaging sites who are not registered before the first F-18-FLT clinical trial plan is finalized will most likely miss the opportunity to join that trial.
Frequently Asked Questions
Q. How do I register?
A. If you would like to join the Network's imaging site registry, click on the "Register" button on the Imaging Site Registry page and complete the enrollment survey.
Q. How will sites be selected for participation in any given multicenter trial?
A. All sites who qualify for a given trial in terms of specific characteristics requested by the clinical trials sponsor, will be recommended for trials participation by the Clinical Trials Network. Final site selection will be at the discretion of the sponsoring drug developer.
Q. Is there a deadline for completing the online registration survey?
A. No, online registration will remain open indefinitely. We will continue to encourage interested imaging sites to join the Network at any time they decide they would like to consider participation in multicenter clinical trials. Registration in the Network will NOT obligate you to participate in any specific trials. You will have the option to participate, or not, as each trial is being initiated. However, only sites registered at the time a particular clinical trial is being structured will be eligible for recommendation by the Network to the drug developing sponsor for participation in that particular trial.
Q. What if the information about my site changes after I have registered?
A. Currently, you should contact the SNM at clinicaltrials@snm.org to submit changes to your profile. Longer term, the registery database will provide self-help tools that will allow you to keep your profile current through an online updater capability.
Q. Once I register, will I be required to participate in all the clinical trials that are sponsored by drug developers?
A. Registration in the Network will NOT obligate you to participate in any specific trials. You will have the option to participate, or not, as each trial is being initiated.
Q. Is it required that we have an on site cyclotron?
A. No. Participation in the imaging site registry only requires imaging capabilities. The registery survey will inquire about which imaging capabilities you have, and which radiopharmaceuticals you have access to. However, whether you manufacturer or purchase your radiopharmaceuticals will have no bearing on your ability to participate.
Q. What is required of a member?
A. Imaging centers in the Clinical Trials Network imaging registry will be asked to participate in an on-going assessment, monitoring, and qualification program to maintain imaging quality and standardization across all participating imaging centers. This program is anticipated to involve annual imaging of the SNM clinical phantom, associated phantom image interpretation, and submission of those images for quality assurance committee review.
Q. Is there a fee? and How much is it?
A. There is currently no fee to participate in the imaging or manufacturing registries, and there is currently no expectation to require fees in the future.
Q. We are interested in providing researchers within the science, technology, and pharmaceutical industries with the facility, infrastructure, and resources (i.e., equipment, services, and information) required to acquire imaging of the human body and brain. Although we would like to register our imaging center, we were not sure if we qualified for the registry since we are an MRI facility opposed to a PET facility. Should we register?
A. The Network mission includes the integration of ALL imaging biomarkers into clinical trials, including MR and CT imaging agents. In addition, it is possible that in the future the Network may be used to drive the standardization of multicenter imaging in clinical trials, even where no imaging agent is necessary (e.g. some MR studies). The focus will continue to be on driving standardization and harmonization between different imaging centers. Non-PET imaging centers are encouraged to register now. By registering now (no cost to you) you will receive regular communications on the progress of the Network.
LAST UPDATED: 6/29/2010