Nuclear clinical trials network expands to Europe

July 31, 2009

SNM’s Clinical Trials Network has expanded to include relationships with European PET radiopharmaceutical manufacturing sites to support molecular and nuclear imaging facilities on the continent that are gearing up to perform scientific studies for the program.

SNM's Clinical Trials Network has expanded to include relationships with European PET radiopharmaceutical manufacturing sites to support molecular and nuclear imaging facilities on the continent that are gearing up to perform scientific studies for the program.

Established in October 2008, the network aims at streamlining drug discovery and development through commercially sponsored, multicenter clinical trials and advanced radiopharmaceutical and biomarkers technologies.

The SNM has developed trial protocols and is beginning to conduct clinical site education, and equipment testing using PET scanner phantoms, designed specifically for the network, to assure consistent site-to-site performance for multicenter pharmaceutical trials run by drug companies that contract for the society's services.

According to the SNM, 217 imaging sites in the U.S., 28 in Europe, and 22 elsewhere in the world have registered for the network.

The SNM announced July 23 that three European radiopharmacy companies have registered their 27 radiopharmaceutical manufacturing sites with the network. They are Advanced Accelerator Applications, Erigal Limited, and IBA Molecular.

Their participation will afford European clinical trial sites the option to obtain investigational imaging agents, such as fluorine-18 3'-deoxy-3'-fluorothymidine (FLT), from a commercial provider instead of having to produce it themselves, said Dr. Michael M. Graham, SNM president and trial network cochair.

The society had intended from its inception to include European sites in the network, Graham said.

"European institutions have an extensive history in clinical trials experience and they bring critical knowledge and capability to the network registries," he said.

The network has also lined up radiopharmacies in the U.S. to supply radiopharmaceuticals to trial sites in this country. In June, PETNet Solutions, Cardinal Health, and IBA Molecular all provided the SNM with access to FDA drug master files for FLT. F-18 FLT PET shows promise for monitoring responses to therapy by noninvasively measuring cell proliferation.

SNM's Clinical Trials Network received investigational new drug status from the FDA for the use of FLT in multicenter studies. Each imaging site that participates in a study will use the society's multicenter IND approval when FLT is employed in its assigned clinical trial.

But instead of having to submit detailed information about in-house production methods, sites will have the option to purchase investigational biomarkers from one of the commercial manufacturers that has provided access to its FDA drug master file to the SNM.

"We hope that having commercial PET radiopharmaceutical producers supply investigational agents will further improve the level of standardization in imaging biomarker production," Graham said. "But this in no way reduces the need for single-site-produced biomarkers. We need both."

The network's success ultimately depends on partnerships with pharmaceutical companies to perform multicenter drug trials through the network. In March, Genentech, a pioneer biotech company in South San Francisco, CA, became the first pharmaceutical concern to contract for the networks' services.