For carcinoid, pancreatic neuroendocrine tumor, and other NET cancer patients seeking the most advanced nuclear medicine opportunities in the United States, Excel Diagnostics and Nuclear Oncology Center in Houston, Texas, in collaboration with the RITA Foundation and RadioMedix, has now received FDA permission for clinical trial of the Ga-68 Octreotate PET/CT scan and is one of a select number of U.S. facilities to participate in the new 177Lu-DOTA0-Tyr3-Octreotate Phase III clinical trial, also known as NETTER-1. Nuclear medicine is used for both diagnosis and treatment in neuroendocrine tumors (NETs).
Ebrahim S. Delpassand, MD, Chairman and Medical Director of Excel Diagnostics, serves as Principal Investigator of the NETTER-1 clinical trial at Excel. NETTER-1 is an international study and Excel Diagnostics is the first center in the United States to recruit and enroll patients and the only non-university center to participate in the trial. It is a multicenter randomized clinical trial of Lu-177 Octreotate PRRT in patients with progressive midgut carcinoid.
The NETTER-1 study will evaluate the efficacy and safety of Lutathera® compared to high dose Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors. According to Dr. Delpassand, “patients will be randomized to receive high doses (60 mg) Sandostatin® LAR versus 30 mg Sandostatin® LAR plus Lu-177 octreotate.” The primary objective of the trial is the assessment of Progression-Free Survival (PFS). Also being studied are safety, Objective Response Rate (ORR), Time to Tumor Progression (TTP), Overall Survival (OS), and Quality of Life (QoL).
Lutathera®, Lu-177 Octreotate, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in differentiated neuroendocrine tumors. The Lu-177 is delivered directly into the tumor cell, acting like a Trojan horse. A Trojan horse in cancer therapy is the use of nanotechnology where cancer-fighting particles are targeted only for the cancer cells, leaving healthy cells alone. Lutathera® also releases a gamma ray, which exits the body and enables physicians to image and evaluate the progress of the treatment via a SPECT (Single Photon Emission Computer Tomography) camera.
The Ga-68 Octreotate PET/CT scan that is being tried at Excel Diagnostics appears to be extremely promising. (Changing Paradigms with Molecular Imaging of Neuroendocrine Tumors, Hoffman and Hicks, Discovery Medicine, July 2012). Preliminary results suggest that the Ga-68 Octreotate PET/CT has the following benefits:
• False negative or positive results are rare
• Lesions as small as 2-3 mm can be visualized
• High resolution images increase the chance of localizing the primary site of the disease which can be hard to visualize on other types of imaging. This has enormous value in patients with functional tumors who can be potentially cured following removal of localized disease.
The Gallium-68 scan, says Dr. Delpassand, appears to be a superior imaging tool because it provides the following:
• excellent resolution of images,
• the ability to quantify tumors and following therapy tumors can be measured by standardized uptake value (SUV) which is not available with an OctreoScan,
• less radiation exposure than an OctreoScan,
• significantly reduced time for the scan — the entire scan is done in 2 hours.
“The FDA has also granted permission to charge for this radiopharmaceutical under expanded access criteria and therefore, this will help coverage by the insurance companies,” adds Dr. Delpassand.
For further information about the Ga-68 Octreotate PET/CT scan or clinical trial participation at Excel Diagnostics, contact Ms. Susan Cork at 713-341-3203 or firstname.lastname@example.org.