News | September 23, 2009

New PET Imaging Biomarker for Cancer Diagnosis Proves Safe in Humans

September 23, 2009 - The results of the Phase 0 (exploratory), or “first-in-human,” study indicated that the bio-distribution of the new agent was recorded at safe levels for clinical use in positron emission tomography (PET) studies, according to a presentation at the World Molecular Imaging Conference in Montreal, Canada.

Siemens Healthcare announced today the initial findings of a new imaging biomarker developed by its molecular imaging biomarker research facility in collaboration with Dr. Jian Q. (Michael) Yu and Fox Chase Cancer Center in Philadelphia, Penn. "These are very exciting initial results," said Jian Q. Yu, M.D., of Fox Chase Cancer Center. "The potential ability to non-invasively determine the level of potency in malignant cancer cells might drastically change the treatment course in individual patients."

The new imaging agent was designed to capture and quantify the cellular expression of CA-IX, an enzyme whose expression has been linked to tumor growth and invasion, as well as hypoxia. CA-IX is an active enzyme, whose expression usually promotes tumor growth and invasion, and thus impairs prognosis. Noninvasive quantification of CA-IX expression may have the potential to characterize the biologic aggressiveness of malignant tumors in an individual, without the need for the invasive collection of tissue samples. The detection of CA-IX in patients may provide a novel approach to predict disease outcomes and efficacious responses to cancer therapy, and, ultimately, help physicians decide on the most effective treatment options for patients.

The agent was also found to be stable for imaging at 133-minutes post injection, which allows a sufficient window for acquiring the image, and that the agent safely clears the body through urinary elimination. The study included initial human data regarding bio-distribution of the new agent, radiation dosimetry levels in normal volunteers and optimal patient imaging parameters using PET. Further study with patients is currently in progress.
Carbonic anhydrase IX (CA-IX) is one subtype of transmembrane carbonic anhydrases, which catalyzes the reversible hydration of carbon dioxide into carbonic acid and is believed to be involved in pH regulation, which is linked to tissue invasion by tumors. The absence of CA-IX expression has been observed in many normal tissues. The abnormal expression of CA-IX has been detected in many carcinomas originating from CA-IX negative tissues including, the brain, kidney, lung, breast and uterine cervical tissues.
 
Phase 0 trials are conducted in accordance with the Food and Drug Adminstration’s (FDA) guidance on exploratory investigational new drug (IND) studies. These types of studies are intended to improve the development of promising drugs or imaging agents by determining at a very early stage if the drug or agent performs as expected, based on earlier results in pre-clinical trials.
 
For more information: www.siemens.com/healthcare and www.fccc.edu

Related Content

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
Axumin PET Agent Added to NCCN Guidelines for Suspected Recurrent Prostate Cancer
News | PET Imaging | February 21, 2018
Blue Earth Diagnostics announced that Axumin (fluciclovine F 18) injection has been added to the National Comprehensive...
A Tc99m SPECT cardiac exam showing myocardial perfusion in the heart.

Technetium-99m is primarily used for the detection of cancer and to assess perfusion defects in the heart caused by heart attacks or other conditions.

Feature | Radiopharmaceuticals and Tracers | February 08, 2018 | Dave Fornell
February 8, 2018 — The U.S.
PET Tracer Measures Damage From Multiple Sclerosis in Mouse Models
News | PET Imaging | January 24, 2018
January 24, 2018 — The loss or damage of myelin, a cellular sheath that surrounds and insulates nerves, is the hallma
Novel PET Tracer Clearly Identifies and Tracks Bacterial Lung Infection

Representative PET/CT images of 18F-FDS and 18F-FDG in inflamed mice. Mice were inoculated with dead K. pneumoniae (10^8 CFU/mL). Imaging was performed for days 1, 2, 3 and 4 using 18F-FDG and 18F-FDS. CT images showed clear inflammation on day 2 and day 3 with corresponding high 18F-FDG uptake on PET. No significant uptake of 18F-FDS was detected for any of those 4 days. Credit: J Li et al., University of Louisville School of Medicine, Louisville, Ky.

News | PET-CT | January 22, 2018
January 22, 2018 — Researchers at the University of Louisville, Kentucky, have demonstrated that a new...
Overlay Init