News | April 14, 2011

Interim Results From Imaging Agent Trial Unveiled

April 14, 2011 – Interim results from a randomized study on the impact of a SPECT imaging system on clinical management and diagnosis of adult patients who exhibit signs or symptoms of parkinsonian syndromes (PS) have been released. The study used GE Healthcare’s DaTscan system.

The results, presented at the 2011 American Academy of Neurology Meeting, are an important step in documenting the value of the system as an adjunct diagnostic tool for use in differentiating between PS and disorders such as essential tremor (ET) that have similar symptoms.

DaTscan was approved by the U.S. Food and Drug Administration (FDA) in January 2011. It is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain.

This multi-center, open label, randomized clinical trial compared the management, diagnosis, confidence of diagnosis (CoD), and quality of life (QoL) at four, 12 weeks and 52 weeks after randomization to either undergo DaTscan SPECT imaging (N=1331 randomized; 119 dosed and scanned) or not (N=136). The full study will evaluate patients through one year from baseline. Interim results showed more patients in the DaTscan group had changes from baseline (pre-DaTscan) diagnosis and their physicians had a higher mean CoD compared with the control group at both four and 12 weeks post-randomization. Additionally, in patients with a management plan at baseline (N=113 DaTscan and 125 control), significantly more DaTscan patients had management changes 12 weeks after randomization (49 percent vs. 31 percent) compared to the control group (p=0.004).

“Interim clinical results show that DaTscan can be useful in providing objective evidence for patients with diagnostic uncertainty,” said Frederick Weiland, M.D., Sutter Medical Group Diagnostic Medical Imaging co-director of nuclear medicine. “In addition, physicians of patients participating in the study had more confidence in their diagnosis and recommended treatment when they had a DaTscan image.”

Fifty thousand to 60,000 new cases of Parkinson’s disease (PD), a form of PS, are diagnosed in the United States each year, but an accurate diagnosis can take up to six years. Many people mistakenly attribute the first symptoms of PD to the normal aging process, and many have misconceptions about diagnosis.

Use of DaTscan imaging may enable appropriate management for adult patients who have signs or symptoms of PS, through timely, appropriate diagnosis. PS occurs when the brain does not get enough dopamine to perform certain functions. This affects the ability of the brain to control movement and other muscle functions.

For more information: www.datscan.com, www.gehealthcare.com

Related Content

Immune Inflammatory Levels Linked to Disease-Free Survival in Prostate Cancer
News | Prostate Cancer | November 19, 2018
Data from a validation study of a high-risk prostate cancer trial suggests that higher levels of pretreatment...
GE Healthcare Recalls Millennium Nuclear Medicine Systems
News | Nuclear Imaging | November 15, 2018
GE Healthcare announced it is recalling its Millennium Nuclear Medicine Systems due to an incident in which the the top...
Life Image and Mendel.ai Bringing Artificial Intelligence to Clinical Trial Development
News | Artificial Intelligence | November 15, 2018
Life Image and Mendel.ai announced a new strategic partnership that will facilitate the adoption and enhancement of...
Artificial Intelligence Predicts Alzheimer's Years Before Diagnosis
News | Neuro Imaging | November 14, 2018
Artificial intelligence (AI) technology improves the ability of brain imaging to predict Alzheimer’s disease, according...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Subtle Medical Showcases Artificial Intelligence for PET, MRI Scans at RSNA 2018
News | Artificial Intelligence | November 13, 2018
At the 2018 Radiological Society of North America annual meeting (RSNA 2018), Nov. 25-30 in Chicago, Subtle Medical...
University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...
MEDraysintell Projects Increasing Mergers and Acquisitions in Nuclear Medicine
News | Nuclear Imaging | November 07, 2018
With the recent announcement by Novartis to acquire Endocyte , interest from the conventional pharmaceutical industry...