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New Imaging Agent Enables Better Cancer Detection, More Accurate Staging

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Key Points

  • Tilmanocept received FDA approval on March 13, 2013.
  • In a phase III clinical trial, researchers found that 99% of sentinel lymph nodes containing blue dye also contained tilmanocept.
  • Of these nodes, 18% were positive for cancer. Tilmanocept detected 94% of these malignancies, whereas blue dye detected 76%.

Researchers at the University of California, San Diego School of Medicine have shown that a new imaging dye, designed and developed at UC San Diego Moores Cancer Center, is an effective agent in detecting and mapping cancers that have reached the lymph nodes. The radioactive dye technetium Tc-99m tilmanocept (Lymphoseek) successfully identified cancerous lymph nodes and did a better job of marking cancers than the current standard dye. Results of the phase III clinical trial published online today in the Annals of Surgical Oncology.

“Tilmanocept is a novel engineered radiopharmaceutical specifically designed for sentinel lymph node detection,” said David R. Vera, PhD, the drug’s inventor and Professor in the UCSD Department of Radiology. “The molecule, developed at UC San Diego School of Medicine, offers surgeons a new tool to accurately detect and stage melanoma and breast cancers while in the operating room.”

Tilmanocept received FDA approval on March 13, 2013,.

Advancing Molecular Targeting

After a cancer diagnosis, surgeons want to be sure that the disease has metastasized to a patient’s lymph nodes, especially the sentinel nodes that may be the first place that a cancer reaches. By surgically removing and examining the sentinel nodes that drain a tumor, doctors can better determine if a cancer has spread.

“Tilmanocept advances the molecular targeting in breast cancer. It’s the first agent that is binding to a lymph node because it is a lymph node that plays an important role in metastasis,” said Anne Wallace, MD, Professor of Surgery, UC San Diego School of Medicine and principal investigator of the study.  “Tilmanocept’s ability to identify more cancer-containing nodes will lead to better postoperative care for patients, especially those patients who had more than one positive sentinel node.”

Tilmanocept vs Blue Dye

Doctors compared injections of tilmanocept and the standard blue dye into the tumor area. Then, using a handheld radiation detector, they found the lymph nodes that had taken up the drugs radioactivity. The researchers found that more than 99% of sentinel lymph nodes containing blue dye also contained tilmanocept. Of these nodes, 18% were positive for cancer. Tilmanocept detected 94% of the malignancies, whereas the blue dye only detected 76%.

“Tilmanocept is just as accurate as current techniques, simple to use, takes less time to find lymph nodes, and is cleared faster from the body. This could standardize the process of lymph node mapping and make the process easier, particularly for less experienced surgeons,” said Dr. Wallace, Chief of Plastic Surgery at UC San Diego Health System and Director of the Breast Care Unit at UC San Diego Moores Cancer Center.

Safety and Efficacy

Tilmanocept’s safety and effectiveness were established in two clinical trials of 332 patients with melanoma or breast cancer. The phase III clinical trial took place at 13 medical centers involving 148 patients who had both melanoma and breast cancer. The most common side effects identified in clinical trials was pain or irritation at the injection site reported by two patients.

Tilmanocept was originally developed at UC San Diego by Dr. Vera. Dr. Wallace advanced the agent through phase I clinical trials with funding provided by the Susan G. Komen Breast Cancer Foundation and the American Cancer Society. The phase III study was supported by Navidea Biopharmaceuticals, Inc, based in Dublin, Ohio.

Study collaborators include: Linda Han, MD, Indiana University Simon Breast Center; Stephen P. Povoski, MD, Wexner Medical Center; Kenneth Deck, MD, South Orange County Medical; Schlomo Schneebaum, MD, Sourasky Medical Center; Nathan Hall, MD, PhD, Wexner Medical Center; Carl K. Hoh, MD, and Karl Limmer, MD, UC San Diego; Helen Krontiras, MD, University of Alabama; Thomas Frazier, MD, Bryn Mawr Hospital; Charles Cox, MD, University of South Florida; Eli Avisar, Sylvester Comprehensive Cancer Center at University of Miami; Mark Faries, MD, John Wayne Cancer Institute; and Dennis King, PhD, and Lori Christman, PhD, STATKING Clinical Services.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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