BridgeMD
New treatment option for Metastatic Solid Tumors
Official title The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.
ClinicalTrials.gov ID: NCT07224464
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Life expectancy of at least 90 days.
- Histologically confirmed advanced metastatic solid tumors located between the thoracic inlet and the pelvic floor, that have progressed on or after...
- Must have measurable disease according to RECIST 1.1.
- Locally advanced or metastatic disease which is not amenable to curative therapy and has progressed on or is intolerant to standard available therapy...
- There must be resolution of all systemic treatment-related adverse events. At least 14 days must have elapsed since the last systemic or radiotherapy...
You likely can't join if
- Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening).
- Received immunotherapy/biological therapy or any other investigational agent in the last 21 days (before screening).
- Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1).
- 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).
- Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton).
- Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility criteria
- Life expectancy of at least 90 days.
- 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...
- Must have measurable disease according to RECIST 1.1.
- 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.
- 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.
- Documented progressive disease confirmed by either CT (chest and abdomen), MRI or PET/CT scan since patient's last cancer therapy.
- No prior history of brain metastasis confirmed by CT or MRI within 30 days prior to treatment.
- Treatment planning CT scan performed within 14 days prior to study treatment.
- Age ≥18 years.
- Rib cage circumference ≤ 90 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- 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 ≤...
- Ability to provide written informed consent document.
- 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
- Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening).
- Received immunotherapy/biological therapy or any other investigational agent in the last 21 days (before screening).
- Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1).
- 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).
- Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton).
- 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...
- Pregnant and/or breastfeeding.
- Unwilling to be abstinent or on contraception for up to 30 days after the last study treatment.
- Presence of electronic or electronically conductive implants or metals in body (verified by screening CT and metal questionnaire).
- Rib cage circumference over 90 cm.
- Unable to provide written informed consent.
- Unable to lay down with hands extended over head.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.