News | Radiopharmaceuticals and Tracers | May 09, 2016

Study Suggests New PET/CT Agent to Diagnose, Manage Neuroendocrine Tumors

Results demonstrate increased accuracy with GA-68 DOTATATE; researchers hopeful for FDA approval

May 9, 2016 — A recent study demonstrates that Ga-68 DOTATATE positron emission tomography (PET)/computed tomography (CT) scans are superior to In-111 pentetreotide scans, the current imaging standard in the United States for detecting neuroendocrine tumors (NETS). The study, reported in the May issue of The Journal of Nuclear Medicine, could significantly impact treatment management.

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, M.D., corresponding author for the study and professor of clinical radiology and radiological sciences at Vanderbilt University School of Medicine, explained, “Our purpose was to evaluate the safety and efficacy of Ga-68 DOTATATE PET/CT compared to In-111 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 Ga-68 DOTATATE PET/CT combined with CT and/or liver magnetic resonance imaging (MRI) changed care in 28 of 78 (36 percent) patients. In addition, Ga-68 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 Ga-68 DOTATATE imaging over the current standard, where available.

While Ga-68 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 said, “Hopefully, our investigation will provide sufficient evidence on the safety and efficacy of Ga-68 DOTATATE 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 explained: “If our evidence results in FDA approval of Ga-68 DOTATATE 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 Ga-68-labeled radiopharmaceuticals, such as Ga-68 DOTATOC and Ga-68 PSMA.”

Authors of the article “Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging and Treatment Management of Neuroendocrine Tumors” include:

  • Stephen A. Deppen, MS, Ph.D., and Gary T. Smith, M.D., of the Veterans Affairs Hospital (VA Tennessee Valley Healthcare System) and Vanderbilt University Medical Center, Nashville, Tenn.;
  • Eric Liu, M.D., of Rocky Mountain Cancer Centers, Denver, Colo.;
  • Jeffrey D. Blume, Ph.D.; Jeffrey Clanton, DPh; Chanjuan Shi, M.D.; Laurie B Jones-Jackson, M.D.; Martin P. Sandler, M.D.; and Dominique Delbeke, M.D., Ph.D., of Vanderbilt University Medical Center;
  • Jordan Berlin, M.D., of Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center;
  • Vipul Lakhani, M.D., of the Oregon Medical Group, Springfield, Ore.;
  • Richard P. Baum, M.D., Ph.D., of the THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging (PET/CT), ENETS Center of Excellence, Zentralklinik, Bad Berka, Germany;
  • Michael Graham, M.D., Ph.D., of the University of Iowa, Iowa City, Iowa; and
  • Ronald C Walker, M.D., of the Veterans Affairs Hospital (VA Tennessee Valley Healthcare System), Vanderbilt University Medical Center, and Vanderbilt-Ingram Cancer Center.

Support for this study was provided by the U.S. Department of Veterans Affairs Merit Review: I01BX007080, Society of Nuclear Medicine and Molecular Imaging Clinical Trials Network, and local institutional and philanthropic gifts.

For more information: www.jnm.snmjournals.org

Related Content

SimonMed Deploys ClearRead CT Enterprise Wide
News | Computer-Aided Detection Software | September 17, 2018
September 17, 2018 — National outpatient physician radiology group SimonMed Imaging has selected Riverain Technologie
Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
The Siemens Biograph Vision PET-CT system was released in mid-2018.

The Siemens Biograph Vision PET-CT system was released in mid-2018.

Feature | Nuclear Imaging | September 07, 2018 | By Dave Fornell
Nuclear imaging technology for both single photon emission computed tomography (SPECT) and positron emission tomography...
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Check-Cap Announces Interim Results of European Study of C-Scan System Version 3
News | Colonoscopy Systems | September 04, 2018
Check-Cap Ltd. announced the interim results for its post-CE approval study of the C-Scan system Version 3, an...
Brain Iron Levels May Predict Multiple Sclerosis Disabilities
News | Neuro Imaging | August 31, 2018
A new, highly accurate magnetic resonance imaging (MRI) technique can monitor iron levels in the brains of multiple...
Study Finds Multiple Sclerosis Drug Slows Brain Shrinkage

An NIH-funded clinical trial suggested that the anti-inflammatory drug ibudilast may slow brain shrinkage caused by progressive MS. Image courtesy of Robert J. Fox, M.D., Cleveland Clinic.

News | Neuro Imaging | August 30, 2018
August 30, 2018 — Results from a clinical...
Rapid Cardiac MRI Technique May Cut Costs, Boost Care in Developing World
News | Magnetic Resonance Imaging (MRI) | August 29, 2018
A newly developed rapid imaging protocol quickly and cheaply diagnosed heart ailments in patients in Peru, according to...
Brain Study of 62,454 Scans Identifies Drives of Brain Aging
News | SPECT Imaging | August 27, 2018
In the largest known brain imaging study, scientists from five institutions evaluated 62,454 brain single photon...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
Overlay Init