Elsevier

Seminars in Nuclear Medicine

Volume 40, Issue 5, September 2010, Pages 327-331
Seminars in Nuclear Medicine

The Clinical Trials Network of the Society of Nuclear Medicine

https://doi.org/10.1053/j.semnuclmed.2010.03.006Get rights and content

The Clinical Trials Network of the Society of Nuclear Medicine was formed to provide quality assurance of both imaging and radiopharmaceutical manufacturing in clinical trials. The intention is to register and qualify a large number (>200) of sites, both in the United States and internationally, to be able to do the positron emission tomography imaging part of clinical trials. Initially, the types of trials to be supported include evaluation of novel radiopharmaceuticals and trials that use approved or experimental radiopharmaceuticals for early assessment of tumor response to novel chemotherapy agents. The Clinical Trials Network is organized into 7 committees that provide overall oversight and strategic guidance, database management, site qualification and monitoring, scanner validation, clinical site orientation, technologist education, trial design, and a manufacturer's registry. At the end of the first year, more than 200 potential clinical trial sites and more than 125 manufacturing sites have expressed interest in participating. The qualification process is well underway. Funding is being provided by 3 large pharmaceutical companies. An investigational new drug application has been obtained for F-18 fluorothymidine that is held by Society of Nuclear Medicine to allow simplification of data management during multisite trials with F-18 fluorothymidine. A second investigational new drug application is in preparation for F-18 fluoromisonidazole. A supply of oncology chest phantoms has been manufactured and have been shipped to numerous sites for scanner validation. Educational materials are being developed for the physicians, technologists, and research coordinators at the sites. This is an important initiative that is likely to help significantly expand the role of molecular imaging and will help bring the right treatment to the right patient at the right time.

Section snippets

New Radiopharmaceuticals

There have been remarkably few new radiopharmaceuticals approved. The reason for this is multifactorial: (1) The projected market for new diagnostic and therapeutic radiopharmaceuticals is relatively small, especially compared with most therapeutic pharmaceuticals. Therefore, the return on investment is not as high. (2) Investigational new drug (IND) applications for radiopharmaceuticals are subject to the same regulatory requirements as for new drugs, which means they come under the same level

Assessment of Response to Therapy

The use of novel imaging techniques can potentially provide sponsors of therapeutic trials an early measure of response, or lack of response, in phase 1 or phase 2 testing. The “go or no-go” decision to develop a new molecular entity for therapy is critically important for pharmaceutical companies because investment in later phase trials can cost millions of dollars to learn that a new therapy does not perform effectively. Making the decision to terminate development of a new drug early is as

Challenges With Molecular Imaging Trials

The pharmaceutical industry's initial experience in trials incorporating PET imaging has not been uniformly successful. The imaging part of the trials can be complex, needs to be scheduled in a consistent relationship to the therapy schedule, and needs to be performed in a consistent and standardized manner with adherence to the clinical trial protocol. Many of the companies and the associated Clinical Research Organizations (CROs) are not familiar with the requirements of PET imaging and the

Accomplishments

Some key accomplishments that have been achieved by the end of the first year of operations are the following:

  • 3 pharmaceutical partners have now joined with the CTN and have agreed to provide financial support of the required infrastructure and processes;

  • The CTN imaging site registry database is functional, and currently includes more than 240 sites worldwide who have expressed interest (more than 25% participation from outside the United States);

  • the manufacturer's registry has been initiated,

Plans

Our goal is to have at least 40 US and 20 non-US sites scanner validated and fully qualified by the end of 2010. The top 3 initiatives that are critical to successful implementation of the CTN, and are the short-term goals for 2010 are:

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