A better way to diagnose and manage neuroendocrine tumors
A recent study demonstrates that 68Ga-DOTATATE PET/CT scans are superior to 111In pentetreotide scans, the current imaging standard in the United States for detecting neuroendocrine tumors (NETS), and could significantly impact treatment management.
In-111-DTPA-octreotide scan (A) demonstrates recurrent mesenteric nodule (arrow) on the anterior view in a patient with a mid-gut carcinoid tumor resected 5 years previously, with no other tumor seen with planar or SPECT/CT (B) images. Ga-68 DOTATATE PET/CT anterior 3D MIP (C) and axial fused images (D) demonstrate other metastases (arrows), changing the surgical plan for resection. Findings were verified at surgery.
Ronald C. Walker, MD
NETS occur mostly in the respiratory and digestive tracts and are usually slow-growing. They can be difficult to diagnose, and many treatment options exist. It's therefore critical to delineate the extent of disease accurately for proper management. While the incidence of NETS is relatively low, with 2.5-5 cases per 100,000 in the United States, data from the National Cancer Institute show a five-fold increase worldwide from 1973 to 2004. NETS can be malignant and, although they comprise less than two percent of gastrointestinal cancers, they are more prevalent than stomach and pancreatic cancers combined.
Ronald C. Walker, MD, corresponding author for the study and professor of clinical radiology and radiological sciences at Vanderbilt University School of Medicine, explains, "Our purpose was to evaluate the safety and efficacy of 68Ga-DOTATATE PET/CT compared to 111In pentetreotide imaging for diagnosis, staging and re-staging of pulmonary and gastroenteropancreatic neuroendocrine tumors." With concerns for patient safety, detailed toxicity data were also collected.
The two imaging methods were performed in 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic (GEP) NETs. The study found that 68Ga-DOTATATE PET/CT combined with CT and/or liver MRI changed care in 28 of 78 (36 percent) patients. In addition, 68Ga-DOTATATE PET/CT correctly identified three patients for peptide receptor radiotherapy who had been incorrectly classified by In-111 pentetreotide. Demonstrating no significant toxicity, lower radiation exposure and improved accuracy, the study makes a strong case for the use of 68Ga-DOTATATE PET/CT imaging over the current standard, where available.
While 68Ga-DOTATATE PET/CT is in widespread use outside of the United States, the U.S. Food and Drug Administration (FDA) has not yet approved its use for the diagnosis, staging and treatment management of NETS. As a result, insurance companies do not cover its use.
Walker says, "Hopefully, our investigation will provide sufficient evidence on the safety and efficacy of 68Ga-DOTATATE PET/CT to the U.S. FDA to allow approval. If so, then patients throughout the United States could soon have access to a higher-quality scan, allowing better patient management decisions while also lowering radiation exposure and shortening examination time." Such approval would also open up the possibility of reimbursement for the scans by third-party payers.
These findings could have an impact on the future of nuclear medicine, as well, as Walker explains: "If our evidence results in FDA approval of 68Ga-DOTATATE PET/CT imaging for routine use in the treatment management of patients with neuroendocrine tumors, it would represent the first approval of a Ga-68-labeled PET imaging radiopharmaceutical in the U.S. This could help pave the way for similar studies to allow approval in the U.S. and elsewhere of other 68Ga-labeled radiopharmaceuticals, such as 68Ga-DOTATOC and 68Ga-PSMA."
Original publication
Stephen A. Deppen, Eric Liu, Jeffrey D. Blume, Jeffrey Clanton, Chanjuan Shi, Laurie B. Jones-Jackson, Vipul Lakhani, Richard P. Baum, Jordan Berlin, Gary T. Smith, Michael Graham, Martin P. Sandler, Dominique Delbeke, and Ronald C. Walker; "Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors"; J Nucl Med; 2016
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Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
