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AGuIX Nanoparticles + Stereotactic Radiation for Brain Metastases
Study Summary
This trial will test whether AGuIX can help radiation work better in treating brain metastases that are difficult to control.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648Trial Design
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Who is running the clinical trial?
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- My melanoma has spread to my brain and is growing despite having immunotherapy.Your kidneys are working well, filtering at a rate of at least 60 mL/min/1.73m2.I am able to care for myself but cannot do normal activities or work.Your doctor thinks you will live at least 3 months based on your overall health.I have brain metastases near critical areas and they've been heavily treated with radiation.My cancer started in my digestive system.I need radiation for more than 10 (or 20 if I had whole brain radiation before) cancer spots.My cancer has spread to the lining of my brain and spinal cord.My cancer has spread, and the largest area is at least 2cm big.My cancer came back in the same area after targeted radiation.You cannot have a brain MRI.I cannot receive gadolinium.My cancer has returned in the brain after full brain radiation treatment.My cancer has spread and formed cyst-like growths.I have a confirmed solid cancer with a brain lesion larger than 5mm.My breast cancer is HER2 positive, as determined by my doctor.I was 18 or older when my brain cancer was diagnosed.
- Group 1: Stereotactic Radiation plus placebo
- Group 2: Stereotactic Radiation plus AGuIX gadolinium-based nanoparticles
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current stance of the FDA on Stereotactic Radiation?
"Even though there is no data affirming its efficacy, stereotactic radiation received a safety score of 2."
Are researchers still looking for test subjects?
"Yes, as of right now this study is still recruiting patients. The initial posting was on September 15th, 2021 with the most recent update being October 19th, 2021."
How many patients are included in the current iteration of this research?
"Yes, this study is still enrolling patients according to the latest information available on clinicaltrials.gov. The trial was created on September 15th, 2021 and updated October 19th, 2021. They are looking for 112 individuals total from 2 different locations."
What is the medical research history of Stereotactic Radiation?
"There are 11 Stereotactic Radiation trials currently underway. Of these active studies, 0 are in Phase 3 testing. Most of the research is taking place in Portland, Oregon; however, there are 28 clinical trial sites for this treatment across the United States."
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