Expanded Access IND
68Ga-PSMA-11, C-11 Acetate, Gallium-68-DOTA-NOC, Gallium-68-DOTA-TATE (NETSPOT) PET/CT Exam Information:
*It is important to note, this is NOT part of a clinical trial program.
The ORI is supporting scheduling of clinical PET/CT imaging exams, for limited indications, using the radiopharmaceuticals 68Ga-PSMA-11, C-11-acetate and Ga-68-DOTA-NOC. These are not FDA-approved drug products. 68-GA-DOTA-TATE(NETSPOT) is FDA approved.
The clinical use of these Investigational New Drugs is occurring under the FDA’s “expanded access” program. We hold an Expanded Access IND for neuroendocrine tumor imaging with 68Ga-DOTA-NOC, as well as an Expanded Access IND for imaging prostate cancer and hepatocellular carcinoma with 11C-acetate. As required by the FDA, the Expanded Access INDs are subject to oversight by the local Institutional Review Board, which requires that we obtain consent from each patient.
The FDA has approved charging for these radiopharmaceuticals at the rate required to recover the costs of their production. The current FDA-authorized charge rate for each radiopharmaceutical, as well as the associated IU Health rates for PET/CT imaging, are provided in the documents available below
At the bottom of this page you will find the documentation we require for verification of eligibility for the C-11 Acetate and Gallium-68 DOTA-NOC & GA-68-DOTA-TATE (NETSPOT) PET/CT scans and for exam scheduling.
Step by step instructions for ordering these exams:
1. The referring physician office will email a request to email@example.com, attaching a completed Eligibility Form (we will obtain our Nuclear Medicine Physician's signature in the form's designated signature field) and Scheduling Request Form (both available below).
2. Once our Nuclear Medicine Physician has signed the completed Eligibility Form, we will contact the patient directly to schedule and confirm the exam time.
3. Upon exam completion, the images will be sent to IU Health PACS and a diagnostic dictation from a Nuclear Medicine physician will be sent to the patients IU Health medical record.
Please note: The referring physician must contact the patient's insurance company to obtain Pre-authorization for the procedure, based on medical need. A Fact Sheet for each scan is provided below, and may be helpful in interaction with the insurance company. We are available to answer questions about the procedure, if necessary. But, we cannot be directly responsible for obtaining the insurance pre-authorization, since this is based on the referring physician’s medical judgment about the health care needs of their patient.
If you have any questions please contact firstname.lastname@example.org.
*Please do not contact IU Health centralized scheduling when scheduling the 11C-Acetate or Gallium-68 DOTA-NOC scans.