Tag Archive for: National Cancer Institute

doctors doing heart surgery

Novel dye may improve outcomes for liver surgery

Researchers at Children’s National Hospital and the National Cancer Institute (NCI) have developed a novel, near‐infrared dye that can help surgeons identify structures and detect leakage during liver surgery, offering a promising tool that may someday improve outcomes for patients undergoing gastroenterology procedures.

The problem has vexed the medical community for some time: Despite advances in bile leak detection, only a third of bile duct injuries are found at the time of surgery, extending hospital stays and increasing the risk of liver failure, sepsis and even death.

Why we’re excited

The new dye – known as Bile Label Dye 760 (BL-760) – provided several promising advantages over existing surgical tools during non-clinical testing. When administered into the liver, BL‐760 was excreted and visible in bile ducts within minutes, without significant or prolonged impact on organ tissue. Its fluorescence against the surgical field also provided a superior view of leaks, offering an opportunity to treat the patient while still in the operating room. Details were published recently in Lasers in Surgery and Medicine.

“BL-760 is a promising option for monitoring the health of the liver during surgery, and we are excited to continue our testing and hopefully see first-in-human trials in the future,” said Richard Cha, Ph.D., principal investigator at the Sheikh Zayed Institute of Pediatric Surgical Innovation, part of the NIH-funded team that developed the dye.

doctors doing heart surgery

The new dye – known as Bile Label Dye 760 (BL-760) – provided several promising advantages over existing surgical tools during non-clinical testing.

The big picture

The dye could significantly advance hepatobiliary and pancreatic (HPB) procedures in years to come. More than 40,000 new cases of liver cancer are diagnosed each year, causing more than 30,000 deaths in the U.S. alone. Gallbladder disease is also one of the most common conditions in the U.S., with more than 20 million people affected annually. In pediatrics, gall bladder removal, or cholecystectomy, is on the rise.

Procedures to treat these diseases have many challenges. During minimally invasive surgery, including laparoscopic cholecystectomy or robot-assisted hepatectomy, surgeons can struggle to precisely identify the bile ducts because of a narrow field of view or because they are embedded in fat or other tissues. Existing FDA-approved contrast agents that can enhance the biliary anatomy such as indocyanine green (ICG) aren’t well tailored for HPB surgeries because of the timing of their administration and their inferior ability to highlight biliary structures. In addition, while pre-operative imaging has improved outcomes, it cannot be used to predict leaks from the surgery itself.

What’s ahead

BL-760 was created at Children’s National and NCI by a team of experts in surgery and engineering, led by Anthony Sandler, M.D., senior vice president and surgeon-in-chief. They hope to continue their testing on the dye in the months ahead. The team was encouraged when Michele Saruwatari, M.D., a Joseph E. Robert Fellow in the Sheik Zayed Institute, recently won first place in the resident and fellow abstract presentation competition at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“Having this tool in the operating room will change outcomes for our pediatric patients,” Sandler said.  “This dye has the potential to become an essential step in liver cancer surgery, cholecystectomy and treating other pediatric diseases like biliary atresia. I look forward to the day when we can get it in the hands of surgical teams.”

Marius George Linguraru

$1M grant funds research on quantitative imaging for tumors

“For children who are at risk of losing their vision, this project will bring a window of opportunity for physicians to start treatment earlier and save their vision,” says Marius George Linguraru, DPhil, MA, MSc.

A team from Children’s National Hospital is part of a project receiving a two-year grant of nearly $1,000,000 from the National Institutes of Health (NIH) for the first pediatric project in the Quantitative Imaging Network (QIN) of the National Cancer Institute (NCI). Marius George Linguraru, DPhil, MA, MSc, principal investigator from the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital in Washington, D.C., is one of two principal investigators on the project, which focuses on developing quantitative imaging (QI) tools to improve pediatric tumor measurement, risk predictions and treatment response. Roger Packer, M.D., Senior Vice President of the Center for Neuroscience & Behavioral Health, Director of the Gilbert Neurofibromatosis Institute and Director of the Brain Tumor Institute, is co-investigator.

The project, in collaboration with Children’s Hospital of Philadelphia and Children’s Hospital Colorado, centers on the most common type of brain tumor in children, called a low-grade glioma. This project focuses on a clinically challenging group of children with neurofibromatosis type 1 (NF1), the most common inherited tumor predisposition syndrome. Nearly 20% of children with NF1 will develop a low-grade glioma called optic pathway glioma (OPG). In children with this type of brain tumor, the growth occurs around the optic nerve, chiasm and tracts, also called the optic pathway, which connects the eye to the brain. OPGs can cause vision loss and even blindness. Permanent vision loss usually occurs between one and eight years of age with doctors closely monitoring the tumor with magnetic resonance imaging (MRI) to assess the disease progression.

“Our traditional two-dimensional measures of tumor size are not appropriate to assess the changes in these amorphous tumors over time or how the tumor responds to treatment,” says Linguraru. “This means physicians have difficulty determining the size of the tumor as well as when treatment is working. Research such as this can lead to innovative medical technologies that can improve and possibly change the fate of children’s lives.”

Dr. Linguraru is leading the technical trials on this project, which take place in the first two years, or phase one, starting in June 2020. Phase one focuses on improving the often inaccurate human measurements of tumor size by developing QI tools to make precise and automated measures of tumor volume and shape using machine learning. In this phase, the project will use and homogenize MRI data from multiple centers to develop predictive models of the treatment response based on the tumor volume that are agnostic to the differences in imaging protocols. By doing this, it will allow physicians to make more informed decisions about the treatment’s success and whether the child will recover their vision.

When phase one is complete, Linguraru and the project’s other principal investigator Robert A. Avery, DO, MSCE, neuro-ophthalmologist in the Division of Ophthalmology at Children’s Hospital of Philadelphia, will initiate the second phase, which includes validating the QI application on data from the first ever phase III clinical trial comparing two treatments for NF1-OPGs. Phase two is scheduled to start in the Summer 2022 and continue through Summer 2025.

“For children who are at risk of losing their vision, this project will bring a window of opportunity for physicians to start treatment earlier and save their vision,” says Linguraru. “For those children who won’t benefit from chemotherapy because the tumor poses no threat to their sight, this project will save them from having to go through that difficult treatment unnecessarily. It will be life-changing for the children and their families, which is what excites me about this QI application.”

This project is a collaboration between Children’s Hospital of Philadelphia and Children’s National Hospital in Washington, D.C., in partnership with Children’s Hospital of Colorado and University of Pennsylvania. Upon project completion, the QI application will provide a precision-medicine approach for NF1-OPGs and improve clinical outcomes for pediatric tumors.

Roger Packer, M.D., elected Pediatric Co-Chair by the National Cancer Institute’s Brain Malignancies Steering Committee

Roger Packer, MD

Roger J. Packer, M.D., Senior Vice President, Center for Neuroscience & Behavioral Health at Children’s National Health System, has been elected by the National Cancer Institute’s Brain Malignancies Steering Committee (BMSC) as the committee’s new Pediatric Co-Chair.

One of 16 steering committees formed in response to the recommendations of the Clinical Trials Working Group mandated by the National Cancer Advisory Board (NCAB), the BMSC’s goal is to promote the best clinical and translational research for patients with brain cancer by critically reviewing Phase 2 and Phase 3 clinical trial concepts.

Dr. Packer also directs the Brain Tumor Institute and is principal investigator for the Pediatric Brain Tumor Consortium (PBTC), formed under the auspices of the National Cancer Institute (NCI). He has worked closely with the NCI and the National Institute of Neurological Disorders and Stroke (NINDS), and has served on multiple committees setting the directions for neurologic clinical and basic science research for the future. Much of Dr. Packer’s clinical research has been translational in nature. He has been part of studies evaluating the molecular genetics of childhood and adult neurologic diseases, and has also coordinated the first gene therapy study for children with malignant brain tumors in the U.S.