Sarah Nanotechnology System for Advanced Metastatic Solid Tumors
This study is testing a new treatment called the Sarah Nanotechnology System for people with advanced (Stage 4) metastatic solid tumors that haven't responded to standard treatments or for whom standard treatments aren't an option. The system uses an intravenous (into a vein) injection of tiny particles called Sarah Nanoparticles (SaNP) that contain iron oxide. After injection, an alternating magnetic field (AMF) is applied to the body, which heats up the nanoparticles in the tumor to destroy cancer cells. This early study aims to find out how safe the Sarah Nanotechnology System is and to determine the best dose and application of the magnetic field. The study plans to enroll 12 participants, but its current status is unclear.
- Study design
- This is an early feasibility study, which means it's one of the first times this treatment is being tested in people. It's an open-label, non-randomized study, meaning everyone knows what treatment they are receiving, and there's no comparison group. The study will involve a small number of participants, with a planned enrollment of 12.
- What's involved
- Study participation involves one intravenous injection of Sarah Nanoparticles. Your upper torso will then be exposed to an alternating magnetic field, with a cooling blanket used to regulate your body temperature.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the treatment day and for up to one month after treatment.
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The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Scott C Lester, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic, Rochester, MN
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Primary safety profile: assessing the number of device related adverse events and serious adverse events.From treatment day and up to 1 month post treatment.
Evaluating the safety profile of the SaNP application via intravenous administration and the safety of the AMF radiation, in metastatic solid tumor patients, by assessing the procedural adverse events, and serious adverse events.
- Primary safety of recommended dose: characterization of protocol dosing regimenFrom treatment day and up to 1 month post treatment.
Determining the recommended dose for the next efficacy study based on the different treatment arms.