The core effort of the PEDIA-SURG Research Group is focused on designing and conducting high-quality clinical trials in pediatric surgery. With expertise in study design and implementation, Drs Lautz and Goldstein collaborate with thought-leaders and innovators across the country and the world. Supported by a team of outstanding Clinical Research Associates and Resident Research Fellows, the PEDIA-SURG group is at the forefront of pediatric surgical clinical research.
Open Trials
A Pilot Study of Intraoperative Visualization of Pulmonary Metastases using the Fluorescent Marker Cytalux for Children and Adolescents Undergoing Pulmonary Metastasectomy
PEDIA-SURG investigators are conducting this first-in-children study examining the safety and utility of the novel fluorescent imaging agent pafolacianine (Cytalux) for detecting metastatic tumor in the lungs
The lung is the most common site of metastatic spread for many pediatric tumors. For many types of tumors, surgery to remove all pulmonary nodules is an essential step in trying to achieve a cure. Finding and removing all metastatic disease in the chest can be a challenge and surgeons are always looking for new tools to help them identify all disease “spots” in the lung. This new tool takes advantage of the fact that the folate-receptor is over-expressed on tumor cells compared to surrounding normal lung. When given through the IV, this dye therefore hones in on the cancer nodules, allowing the surgeon to visualize them with the near-infrared camera during surgery.
This study is assessing the safety of this new medication in children and determining the accuracy of this new tool for identifying viable metastatic tumor.
Status: Enrolling
Full trial details available at clinicaltrials.gov
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Dr Lautz is the vice-chair of this international phase III randomized-controlled trial sponsored by the Children’s Oncology Group investigating the optimal surgical approach for pulmonary metastasectomy in children, adolescents and young adults with metastatic osteosarcoma.
For patients with osteosarcoma which has spread to the lung, complete removal of all metasatatic disease is important for cure. By making a larger incision to allow the surgeon to feel all surfaces of the lung, they can find additional small foci of tumor that was too small to detect on CT scan in 20-25% of cases. However, it has never been proven that removing these microscopic nodules improves survival. Advocates for thoracoscopy (minimally-invasive surgery) argue that postoperative pain and recovery is improved with this approach and that these microscopic nodules can be removed later if they start to grow.
Status: Enrolling
Full trial details at clinicaltrials.gov
Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
PEDIA-SURG investigators will be participating in this innovative trial supported by St Jude Children’s Research Hospital investigating a novel method with fluorescent-guided surgery for determining whether abdominal tumors have metastasized to adjacent lymph nodes.
Full trial details at clinicaltrials.gov
Multicenter, Open-Label Trial to Evaluate The Safety and Tolerability of Intravenous Eravacycline in Children from 8 Years to Less than 18 Years of Age with Complicated Intra-abdominal Infections (CIAI)
Eravacycline (Xerava®) is a new tetracylcine antibiotic with broad spectrum activity against several multi-drug resistant organisms associated with complicated intr-abdominal infections (cIAIs). It has demonstrated non-inferiority to meropenem (IGNITE4; NCT02784704) and is FDA approved for use in adults ages 18 years and older. In the hopes of expanding this exciting new antibiotic to children, we are partnering with Tetraphase Pharmaceuticals, Inc. as part of a multi-center, phase II clinical trial to investigate the efficacy and safety of eravacylcine in children (ages 8-17 years) with cIAI.
ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06794541
Status: Enrolling
Completed Trials
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near-infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
The PEDIA-SURG research group was the sole pediatric site which enrolled patients on this phase III trial sponsored by Astellas Pharmaceuticals. The purpose of this study is to determine whether Fluorescent-guided surgery with this novel agent (ASP5354) can aide the safe detection of the ureter during surgery. The study is complete with results pending.
Finding and protecting the ureter is an important part of many operations in the abdomen and pelvis. Although injury to this structure is rare, surgeons are always looking for new ways to help avoid this serious complication. Current options for facilitating identification of the ureter require an additional intervention with a camera placed in the bladder to guide a “stent” up into the ureter. This new non-invasive approach has the potential to provide equivalent benefit for “lighting up” the ureter.
This study is assessing the safety of this new medication in children and determining the quality of ureter visualization with and without this new tool.
Trial Details at clinicaltrials.gov
Status: Enrollment Complete
ENhanced Recovery in CHildren Undergoing Surgery (ENRICH-US)
As site PI, Dr Goldstein enrolled patients on this trial aimed at learning more about the clinical effectiveness and examining obstacles to implementing a Perioperative Enhanced Recovery Protocol (ERP) in pediatric surgery.
Status: Enrollment Complete
Full trial details available at clinicaltrials.gov