RecruitingNot applicable

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

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Injections, MRI scans, Heart tracing (ECG), Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Examples of devices that produce non-ionizing radiation are MRI machines, cell phones, Wi-Fi, microwave ovens, and sunlight."
  • "Treatment Procedure: On the treatment day, participants undergo laboratory tests and ECG assessment before SaNP infusion."
  • "Approximately four hours post-infusion, participants are positioned within the EIS coil for AMF irradiation while covered by a cooling blanket, and analgesic administration per physician discretion."
  • "Follow-up assessments occur at 7 ± 2 days and 30 ± 5 days post-treatment and then every 3-6 months up to 5 years for long-term safety surveillance."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and dose of the Sarah Nanotechnology System, which uses tiny iron-containing particles and a magnetic field to heat tumors. It is for adults with stage 4 solid tumors that have spread and have not responded to standard treatment, or who have declined standard treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with an expected lifespan of at least 90 days.
  • Have solid tumors confirmed by a tissue test, located between the base of the neck and the bottom of the pelvis. The cancer cannot be cured or treated with surgery or local treatments.
  • Cancer has grown despite standard treatment, or you cannot tolerate that treatment. Tumors must be measurable, and scans must show cancer growth since your last cancer treatment.
  • Have recovered from side effects of past cancer treatment. At least 14 days must pass after your last whole-body cancer treatment or radiation before screening.
  • Have never had cancer spread to the brain, with a CT or MRI scan within 30 days before treatment. Have a treatment-planning CT within 14 days before treatment.
  • Can care for yourself and are up and about more than half of waking hours. Your rib cage measures no more than 90 cm around.
  • Blood tests must show enough healthy blood cells and good enough liver and kidney function at screening and on treatment day.
  • Can give written consent to join. A CT scan and questionnaire must confirm no electronic implants or metal in your body.

Who can't join

  • Had chemotherapy, radiation, or hormone therapy within 14 days before screening; or immune-based, biological, or experimental treatment within 21 days before screening.
  • Still have side effects from past cancer treatment that are more than mild.
  • Have cancer in the brain, or have had it there before.
  • Have a known allergy to substances similar to those used in this treatment, such as PEG 20,000.
  • Have an uncontrolled illness, such as an infection, heart problem, or mental health condition, that could make joining unsafe or make study instructions hard to follow.
  • Are pregnant or breastfeeding, or will not avoid sex or use birth control for up to 30 days after the last study treatment.
  • Have electronic implants or metal in your body, or your rib cage measures more than 90 cm around.
  • Cannot give written consent or cannot lie down with your hands extended over your head.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Locally advanced or metastatic disease which is not amenable to curative therapy and has progressed on or is intolerant to standard available therapy as deemed by the investigator. 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. Documented progressive disease confirmed by either CT (chest and abdomen), MRI or PET/CT scan since patient's last cancer therapy. 7. No prior history of brain metastasis confirmed by CT or MRI within 30 days prior to treatment. 8. Treatment planning CT scan performed within 14 days prior to study treatment. 9. Age ≥18 years. 10. Rib cage circumference ≤ 90 cm. 11. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 12. Patients should have sufficient organ and bone marrow function on screening day and on procedure day as defined below: Leukocytes ≥3,000/mcL Absolute neutrophil count ≥1,500/mcL Platelets ≥100,000/mcL Total bilirubin ≤ 2.5 x limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤5 x institutional ULN Creatinine Glomerular filtration rate (GFR) ≥50 ml/min/1.73 m2 for patients with creatinine levels above institutional normal. 13. Ability to provide written informed consent document. 14. Confirmation that patient has no electronic or electronically conductive implants or metals: * Via a review of the CT scan * Metal questionnaire filled in by patients Exclusion Criteria: 1. Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening). 2. Received immunotherapy/biological therapy or any other investigational agent in the last 21 days (before screening). 3. Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1). 4. Presence of brain metastases or prior history of brain metastases (if no prior history, confirmed by CT or MRI within 30 days prior to treatment). 5. Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton). 6. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, ischemia, or psychiatric illness) that in the opinion of the investigator would either limit compliance with study requirements or put participant at risk. 7. Pregnant and/or breastfeeding. 8. Unwilling to be abstinent or on contraception for up to 30 days after the last study treatment. 9. Presence of electronic or electronically conductive implants or metals in body (verified by screening CT and metal questionnaire). 10. Rib cage circumference over 90 cm. 11. Unable to provide written informed consent. 12. Unable to lay down with hands extended over head.

Study sites (1)

MN