The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
New Phase Ltd.
Study ID
NCT07224464
Status
Recruiting
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Conditions

  • Metastatic Solid Tumors
  • Stage 4 Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The 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. — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Level 1
    1.2 mg/kg of SaNP (Sarah nanoparticles) with 12-15 min of AMF irradiation
  • Experimental: Level 2
    1.2 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF irradiation
  • Experimental: Level 3
    1.8 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF

Primary Outcome Measure

Primary safety profile: assessing the number of device related adverse events and serious adverse events. [ Time Frame: From treatment day and up to 1 month post treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Scott C Lester, M.D.
[email protected]

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By research site
Mayo Clinic· Rochester, MN

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