Vanderbilt Nuclear Medicine Physicians Provide Key Evidence to FDA for Approval of New PET Imaging Agent

Krystyna Barnard
June 8, 2016

The U.S. Food and Drug Administration (FDA) recently approved a new positron emission tomography (PET) imaging agent, 68Ga-DOTATATE, as a result of key evidence provided to them by nuclear medicine physicians in the Department of Radiology.

68Ga-DOTATATE, a synthetic somatostatin analog, binds eight times more strongly than the existing imaging agent, 111In-pentetreotide, to somatostatin receptors found in neuroendocrine tumors (NETs) in adult and pediatric patients.

For the last six years, nuclear medicine physicians at Vanderbilt and the Nashville Veterans Administration Hospital, in collaboration with Vanderbilt biostatisticians and clinical care providers, and advisors at the FDA and Society of Nuclear Medicine and Molecular Imaging’s (SNMMI) Clinical Trial Network, designed and conducted a trial (NCT01396382) that would provide the needed evidence on the safety and efficacy of 68Ga-DOTATATE.

Seventy-eight patients participated in the clinical trial, which found that 68Ga-DOTATATE, when compared with 111In-pentetreotide, produced higher quality images in a significantly shorter period of time and also reduced the patient’s overall radiation exposure. The use of 68Ga-DOTATATE improved treatment for 36 of the 78 (46 percent) patients, with no adverse side effects of the imaging agent requiring treatment.

“Given the lack of significant toxicity, lower radiation exposure and improved accuracy, the investigation concluded that 68Ga-DOTATATE imaging should be used instead of 111In-pentetreotide imaging where available,” said Ronald Walker, M.D., Professor of Clinical Radiology and Radiological Sciences.

In its announcement, the FDA stated that early detection of NETs in adults and children is critical, and that the data presented in the study confirmed the success of 68Ga-DOTATATE imaging in locating NETs in adults and children.

Nuclear medicine physicians in the Department of Radiology who collaborated on the clinical trial included Walker, Martin Sandler, M.D., Gary T. Smith, M.D., and Dominique Delbeke, M.D., Ph.D. Jeff Clanton, D.Ph., BCRP, performed the compounding.

To read the FDA’s full announcement, click here.

The study appears in SNMMI’s Journal of Nuclear Medicine here. 

An anterior image from a 111In-pentetreotide scan (A) demonstrates recurrent tumor at one location (arrow). The corresponding 68Ga-DOTATATE image (B) demonstrates an additional focus of tumor in the upper mid abdomen (arrows). (Photo courtesy of Ronald Walker, M.D.)