Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.
New Phase Ltd.
Summary
This is a sequential, dose-escalation, non-randomized, prospective, early feasibility trial. The goal of this clinical trial is to gather information on the safety and the recommended dose of the Sarah Nanotechnology System. Eligible participants have stage 4 metastatic solid tumor(s), that is(are) not responding to conventional treatment or have declined standard treatment options. The main question it aims to answer is: • What is the safety profile of the Sarah Nanotechnology System and which field strength and time of irradiation are safe for people? Study participation involves: * One intravenous injection (through a vein in the arm) of a solution that contains tiny particles (nanoparticles) containing iron oxide. The nanoparticles are delivered to the tumor(s) through blood circulation. * About 4 hours after injection of the nanoparticles, participants are placed inside a machine (magnetic field system) where the upper torso will be exposed to low frequency (\~300 kHz) alternating magnetic field (AMF) radiation. This type of radiation, unlike CT or X- rays, is non-ionizing. Non-ionizing means radiation that lacks the energy to remove electrons from an atom. Examples of devices that produce non-ionizing radiation are MRI machines, cell phones, Wi-Fi, microwave ovens, and sunlight. The AMF heats up the iron oxide core in the nanoparticles, due to their magnetic properties, which in turn causes the temperature to increase within the tumor(s). Because cancer cells are more sensitive to heat than normal cells, the heat will damage the cancer cells potentially without harming the surrounding healthy tissues. * During the treatment participants are covered by a cooling blanket to control body temperature, which will be monitored continuously throughout the procedure. * Participants are followed up at 1 week and 1 month, and up to 5 years after the one-time treatment.
Description
This is a sequential, open-label, dose-escalation, non-randomized, prospective early feasibility clinical investigation designed to evaluate the safety of the Sarah Nanotechnology System, comprising intravenously administered Sarah Nanoparticles (SaNPs) in combination with a low-frequency Alternating Magnetic Field (AMF) generated by the Electromagnetic Induction System (EIS). The purpose of the study is to assess the safety profile of the SaNP and AMF combination and to identify the recommended dose and irradiation parameters for a subsequent feasibility study. The study will also provide in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Life expectancy of at least 90 days. 2. Histologically confirmed advanced metastatic solid tumors located between the thoracic inlet and the pelvic floor, that have progressed on or after standard therapy and are ineligible for surgical resection or local therapies. 3. Must have measurable disease according to RECIST 1.1. 4. Patient has exhausted all standard treatment options. 5. There must be resolution of all systemic treatment-related adverse events. At least 14 days must have elapsed since the last systemic or radiotherapy treatment before screening visit. 6. Docum…
Interventions
- DeviceThe Sarah Nanotechnology System - intended to deliver thermal energy to malignant cells for the purpose of thermal destruction of these cells in patients with advanced metastatic solid tumors.
This intervention includes the use of intravenus injection of Sarah Nanoparticles (SaNP) containing iron oxide core, together with non-ionizing alternating magnetic field (AMF) radiation.
Location
- Mayo ClinicRochester, Minnesota