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Lauren Dubinsky, Senior Reporter | May 11, 2016
A and B are In-111-DTPA-octreotide
scans and C and D are
Ga-68 DOTATATE PET/CT scans
In-111 penetetreotide is the current imaging standard in the U.S. for detecting neuroendocrine tumors (NETS), but that may soon change. Gallium-68 DOTATATE PET/CT scans are superior to In-111 penetetreotide scans for NETS detection and can significantly affect treatment management, according to a new study published in
The Journal of Nuclear Medicine.
"I think that Ga-68 DOTATATE PET/CT will replace In-111 penetetreotide when and where it is available," Dr. Ronald C. Walker, corresponding author of the study and professor at Vanderbilt University School of Medicine, told HCB News.
For this to happen, Walker said Ga-68 generators would need to be available within a one-hour driving range of the facility, because the Ga-68 DOTATATE must be compounded by a radiopharmacy on the same day it will be used for scanning.
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That is not the only hurdle. At present, Ga-68 DOTATATE is not FDA-approved, but Walker believes the drug will be cleared on or around June 1, 2016.
For the study, two imaging methods were performed in 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic (GEP) NETS. The researchers found that Ga-68 DOTATATE PET/CT combined with CT and/or liver MR changed care in 28 of those 78 patients.
In addition, Ga-68 DOTATATE PET/CT correctly identified three patients for peptide radiotherapy who had been incorrectly classified by In-111 penetetreotide. It was also associated with no significant toxicity, lower radiation exposure and improved accuracy.
But since Ga-68 DOTATATE doesn't have FDA approval yet for the diagnosis, staging and treatment management of NETS, insurance companies don't cover it. Walker hopes that their research will provide enough evidence of the safety and efficacy of the drug for the FDA.
Once it's granted FDA approval, it will take a few months before approved Appropriate Use Criteria are established and a billable code is released by CMS. Walker hopes that will take place in the next six to nine months after FDA approval is granted.
"For people outside the range of local availability, they will have the choice of continuing to receive an In-111 penetetreotide scan or traveling to where a Ga-68 DOTATATE PET/CT scan can be performed," said Walker.
