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A team from the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) is participating in the Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy added to Chemotherapy Treatment of Pancreatic Tumors (study number HP-00093785). UMGCCC is the first and only cancer center in the world to offer this groundbreaking treatment, in partnership with study sponsor NeoTherma Oncology.

Led by principal investigator Jason Molitoris, MD, PhD, Assistant Professor, Department of Radiation Oncology, University of Maryland School of Medicine, the early feasibility study aims to evaluate the safety and functionality of a new, noninvasive device that delivers heat energy in conjunction with standard chemotherapy for the treatment of pancreatic ductal adenocarcinoma (PDAC) with and without metastatic disease.

Study participants have a series of six study-related visits over three months, including one screening, four treatments and one follow-up visit. All patients on the protocol have been recommended to receive chemotherapy prior to surgery (standard of care therapy) by a multidisciplinary team. The current standard of care treatment for PDAC when surgery is not an option is chemotherapy that consists of about four months of treatment. 

The investigational device delivers energy to heat and produce a “fever range” temperature within the pancreas in subjects whose tumors are to be treated with chemotherapy. Past studies have shown that hyperthermia may increase the effectiveness of chemotherapy. This device uses nontoxic radiofrequency energy to heat the tumor and adjacent tissue, enabling more effective chemo-, radio- and immunotherapies.

During the thermal therapy, patients are positioned on an MRI table, and physiological changes are monitored with temperature probes. Treatment planning, control, and monitoring are supported by advanced software. The treatments take up to 70 minutes with the heat on, allowing up to 30 minutes to heat the tumor to the target temperature and then maintaining that temperature for up to 30 minutes. A short MRI scan (approximately 10 minutes) is taken before and after the hyperthermia procedure to measure blood flow in and around the tumor. The tumor will be assessed for resectability after two months and after four months.

The study’s primary objective is to evaluate the device’s ability to achieve and maintain target tumor temperatures. As a secondary objective, the study seeks to assess intended biological and clinical effects. Benefits of hyperthermia treatment include improved blood flow, enhancing delivery of chemotherapy and reoxygenating the hypoxic tumor microenvironment to enhance efficacy. Hyperthermia helps render damage to cancer cells (by chemotherapy and radiotherapy) permanent and increases cancer cells’ susceptibility to chemotherapy and radiotherapy during cellular reproduction. Lastly, hyperthermia activates heat shock proteins and helps initiate a potent immune response. The research team will evaluate the device’s performance relative to these expected benefits. 

Work like this has the potential to increase the effectiveness of existing PDAC treatments, offering hope for this patient population. 
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For More Information

Phone: 410-328-6080

Study PI: Jason Molitoris, MD, PhD Assistant Professor jmolitoris@som.umaryland.edu

 

 

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