5
Participants
Start Date
August 15, 2023
Primary Completion Date
February 28, 2024
Study Completion Date
April 30, 2024
VectRx Thermal Therapy
Subjects will receive VectRx thermal treatment added to 2 cycles of chemotherapy regimen. The VectRx device will be used under continuous investigator monitoring of internal tissue temperatures via real-time temperature probe data, as well as clinical signs and symptoms reflecting the objectives described above. Up to 5 study subjects will be treated. They will complete VectRx treatment during day 1 prior to 5-FU based (e.g., mFOLFIRINOX) or Gemcitabine based (e.g., Gemcitabine/Nab Paclitaxel) chemotherapy infusion. Thermal treatment will be carefully ramped-up to achieve staged goals of average tumor temperatures between 38°C and 43°C for total treatment times up to 30-70 minutes. The target temperature will be 41.5°C.
RECRUITING
University of Maryland, Baltimore
Lead Sponsor
Collaborators (1)
University of Maryland, Baltimore
OTHER
Databean
INDUSTRY
NeoTherma Oncology
INDUSTRY