LINCOLN, Neb., March 29, 2017 /PRNewswire/ -- Building on more than three decades of pre-clinical research experience, LI-COR Biosciences is sponsoring its first clinical trial for an infrared imaging agent to be used in hysterectomy patients. The Phase 1/2a Safety and Efficacy trial is being conducted with the University of Alabama at Birmingham Hospital. The study will use an investigational near-infrared contrast agent manufactured by LI-COR with the hope of delineating the ureter, the passage between kidney and bladder.
During minimally invasive hysterectomy surgeries, it is important to identify the ureter in order to avoid inadvertent injury and thus, causing considerable harm to the patient. The purpose of this study is to evaluate whether surgeons can visualize the ureter more clearly when the LI-COR contrast agent is administered at the time of surgery.
"Our ultimate goal is to help improve patient outcomes for surgeries where there is risk for damage to the ureter, in addition to aiding surgeons to better manage risk of injury to their patients," says Bambi Reynolds, LI-COR senior business development manager. "We anticipate enrolling subjects in the study in early April, 2017."
LI-COR is currently involved in 15 clinical trials worldwide for intraoperative surgical solutions using its near-infrared dyes. This trial represents the first study that the company is directly sponsoring. If studies demonstrate the safety and efficacy of the near infrared imaging agent, LI-COR plans to seek approval from the US Food and Drug Administration and to commercially manufacture the product at its Lincoln, Nebraska facility.
LI-COR introduced the world's first near-infrared DNA sequencer for non-clinical research use in 1992 and has continued to develop innovative solutions for pre-clinical and basic science research including targeting agents and instrumentation for cancer research as well as small animal live imaging. The company also offers research and manufacturing custom services for imaging agents used in basic research, pre-clinical, and early phase clinical studies.
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During minimally invasive hysterectomy surgeries, it is important to identify the ureter in order to avoid inadvertent injury and thus, causing considerable harm to the patient. The purpose of this study is to evaluate whether surgeons can visualize the ureter more clearly when the LI-COR contrast agent is administered at the time of surgery.
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"Our ultimate goal is to help improve patient outcomes for surgeries where there is risk for damage to the ureter, in addition to aiding surgeons to better manage risk of injury to their patients," says Bambi Reynolds, LI-COR senior business development manager. "We anticipate enrolling subjects in the study in early April, 2017."
LI-COR is currently involved in 15 clinical trials worldwide for intraoperative surgical solutions using its near-infrared dyes. This trial represents the first study that the company is directly sponsoring. If studies demonstrate the safety and efficacy of the near infrared imaging agent, LI-COR plans to seek approval from the US Food and Drug Administration and to commercially manufacture the product at its Lincoln, Nebraska facility.
LI-COR introduced the world's first near-infrared DNA sequencer for non-clinical research use in 1992 and has continued to develop innovative solutions for pre-clinical and basic science research including targeting agents and instrumentation for cancer research as well as small animal live imaging. The company also offers research and manufacturing custom services for imaging agents used in basic research, pre-clinical, and early phase clinical studies.
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SOURCE LI-COR Biosciences
