Gallium-68 DOTATOC PET/CT to Join Gallium-68 DOTATATE PET/CT as an Approved Agent for Imaging of Neuroendocrine Tumors
It was close to two years ago that the September 2017 issue of the Journal of Nuclear Medicine featured a research study and perspective article making the case for the approval of Gallium-68 DOTATOC PET/CT, another new imaging agent to assess neuroendocrine tumors (NETs) in scans. Authors found Gallium-68 DOTATOC superior to decades-old methods for disease staging, treatment planning, and identifying unknown primary sites. The study, however, did not compare Gallium-68 DOTATOC to Gallium-68 DOTATATE, which was approved by the U.S. Food and Drug Administration (FDA) in June 2016. On August 21, 2019, the FDA approved the application for Gallium-68 DOTATOC.
Advocacy for expanding options in imaging
Josh Mailman, a member of NETRF Board of Directors, and President, NorCal CarciNET Community, wrote an invited perspective introducing a meta-analysis of Gallium-68 DOTATOC by Dr. . Josh first underwent a PET/CT scan with Galium-68 DOTATOC in 2008 in Europe (where it is was available). “DOTATOC and other targeted peptides will give clinicians new tools to work with in the management of NET patients,” wrote Mailman. “More tools will continue to increase access for patients to undergo diagnostic imaging and improved outcomes.”
Gallium-68 DOTATOC is one of a few imaging agents that help radiologists “see” NETs on PET/CT scans. It is injected in advance of a patient’s scan so it can bind to tumor receptors. Many of the typical imaging agents used in PET/CT scans don’t work with NETs.
A deep dive into data
Lead investigator Michael Graham, M.D., Ph.D., and colleagues in the Division of Nuclear Medicine, Department of Radiology, University of Iowa, submitted their published data on Galium 68-DOTATOC to FDA in an application for its approval. Graham’s analyses proved it was more effective than 111In-octreotide, which has been used for more than two decades. Their search of medical journals identified 468 articles, which they narrowed down to 17 studies. Graham then analyzed the findings of each study to see if they came to similar conclusions.
Graham found alignment among the 17 studies. “The results that have been reported are remarkably consistent and there is little question that this agent is safe, effective, and more accurate than 111In-octreotide, the standard for the past 22 years,” he wrote.
Significant benefits identified
Graham’s analysis found Gallium-68 DOTATOC effective in multiple ways:
- Accurately detecting NETs when they are there (and not detecting them when they were not there, also called false-positive results) (overall sensitivity and speciﬁcity of 93%)
- Detecting an unknown primary tumor site in patients with extensive metastatic disease (overall success rate of 44%)
- Helping tailor treatment to an individual’s disease (51% of doctors changed patients’ treatment plans based on test results)
Data showed Galium-68 DOTATOC to be less effective in identifying NETs in unusual/complex cases, when the diagnosis of NETs had not been established, or when other tests were inconclusive. Many of the studies included in Graham’s analysis were conducted outside the U.S. The studies analyzed were published between 2001 and 2015.
Gallium-68 DOTATOC also offers improved convenience for patients. It takes considerably less time, only a few hours, compared to a few days for 111In-octreotide. In addition, it does not require the use of laxatives.
Both Graham and Mailman concluded, “Gallium-68 DOTATOC appears to be an excellent imaging agent to assess patients with a known NET and frequently leads to a change in management.”