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WAUKESHA, WI. - GE Medical Systems
, has signed a clinical trial agreement with the Cancer Imaging Program
of the National Cancer Institute (NCI) for multi-site clinical trials of 18F-Fluorothymidine (FLT) as an agent for positron emission tomography (PET), applied to the management of patients with cancer.
FLT is a PET radiopharmaceutical used to image DNA synthesis, showing high contrast in the presence of cellular proliferation in tumors and other proliferating tissues. FLT has shown preliminary promise for the in-vivo imaging of cellular proliferation.
The monitoring of the anti-proliferative effects of chemotherapeutic agents may be important in the management of patients with cancer. An imaging agent that can provide an early assessment of an agent's anti-proliferative activity may assure that patients receive effective therapy.
The NCI will sponsor clinical trials at Johns Hopkins Medical Institutions, Virginia Commonwealth University Medical Center, Massachusetts General Hospital, the University of Washington and the National Institutes of Health Clinical Center. GE Medical will provide TRACERlab FX synthesis systems to produce FLT for the clinical work that will be conducted at these sites.
It is anticipated that FLT will be one of the first PET agents for which there will be a United States Food and Drug Administration Investigational New Drug (IND) proceeding for the NCI-sponsored multi-site trials. This will also be the first clinical trial of an imaging agent supported by the General Electric Company.
"Today, cancer therapies are often given empirically: a treatment is provided to five or 10 people, and it may work in one or two," said, Dr. James Thrall, Chief of Radiology, Massachusetts General Hospital. "We prefer to give patients therapy that is very likely to be effective.
"By using agents like FLT that can specifically image proliferation and other aspects of tumor biology, we can look at tumors before and soon after treatment to determine reliably whether a given therapy will be effective or not," Thrall said. "The idea is to personalize therapy by using PET imaging of the cancer to choose the right treatment and enable the patient to avoid inappropriate therapy."
GE Medical technology will play an essential role in enabling the multi-site trials. Each site will use TRACERlab FXN synthesis boxes in an identical setup with standard operating protocols, ensuring that FLT is synthesized in a reproducible manner across all clinical sites. This, in turn, enables data from all sites to be reliably compared.
"We are proud to collaborate with the National Cancer Institute on this program," said Joe Hogan, President & CEO, GE Medical Systems. "This study can help advance the state of the art in molecular imaging to support better clinical diagnosis, staging, therapy and follow-up for cancer care."
Besides the TRACERlab FXN synthesis equipment, four out of five of the clinical sites will use GE Medical PET/CT or PET systems in the patient trials. Under the terms of the agreement with the NCI, GE Medical Systems also will be responsible for developing the standard FLT synthesis software and procedures.