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SRT vs GammaTile Therapy for Brain Tumor
Study Summary
This trial will compare the efficacy and safety of two treatments for metastatic tumors.
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.Trial Design
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Who is running the clinical trial?
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- I have a brain lesion between 2.5 and 5.0 cm or a smaller one needing surgery.I have 1-4 new brain tumors from cancer that started elsewhere.I can sign or have someone legally authorized to sign for me the consent forms for this study.I am mostly able to care for myself.My brain scan shows all non-primary cancer spots are smaller than 4.0 cm.I am under 18 years old.I am 18 years old or older.My doctor expects me to live 6 months or more with my current treatment plan.My daily activity is significantly limited due to my health.I am not on any treatments that would affect the study's results.My kidney and liver are healthy enough for surgery, according to my doctor.My cancer is a type of germ cell tumor, small cell carcinoma, or lymphoma.I have had whole-brain radiation therapy for brain metastases.My cancer spread is more than 5mm away from the optic nerve and not in my brainstem.I understand the study, can consent, follow treatments, and attend follow-ups.I am fluent in English or Spanish.I am willing to use birth control during and up to 3 months after the study.My cancer has spread to the lining of my brain and spinal cord.I haven't had radiation or surgery on my current cancer spots, but I've had up to 2 SRT treatments on old spots far from my main cancer spot.
- Group 1: Surgical Resection and GammaTile Therapy
- Group 2: Surgical Resection and Stereotactic Radiation Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 are some risks associated with Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)?
"There is evidence backing both the efficacy and safety of Gamma Tile-Surgically Targeted Radiation Therapy (STaRT), which is why it received a score of 3."
Are there different branches handling this research in different ways?
"There are 9 sites running this trial at the moment, with locations in Los Angeles, Atlanta, Houston and other cities. If you are planning on participating in this trial, it would be most convenient for you to choose the location nearest you to avoid any unnecessary travel."
How many individuals are being research subjects in this trial?
"The sponsor, GT Medical Technologies, Inc., needs to recruit 180 eligible patients from multiple clinical trial sites including Keck Hospital of Usc in Los Angeles, California and Piedmont Hospital in Atlanta, Georgia."
Are volunteers still being taken for this experiment?
"That is accurate, the listing on clinicaltrials.gov notes that this research is looking for subjects. The trial was established on April 6th 2021 and was last updated September 19th, 2022. In total, they are hoping to enroll 180 people at 9 different facilities."
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