Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors

NAUnknownINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

August 15, 2023

Primary Completion Date

February 28, 2024

Study Completion Date

April 30, 2024

Conditions
Pancreatic Cancer
Interventions
DEVICE

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.

Trial Locations (1)

21201

RECRUITING

University of Maryland, Baltimore

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

University of Maryland, Baltimore

OTHER

collaborator

Databean

INDUSTRY

lead

NeoTherma Oncology

INDUSTRY

NCT05959395 - Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors | Biotech Hunter | Biotech Hunter