Clinical trials FAQ

A clinical trial is a research study that helps doctors and scientists discover new ways to prevent, diagnose, or treat diseases and medical conditions. Clinical trials follow a structured process to ensure each step is carefully designed to answer key medical questions. Clinical trials may involve testing new treatments, drugs, or medical devices, or comparing existing options to see which one works best.

A randomized controlled trial (RCT) is a type of clinical study used to find out if a new treatment or medical approach works. In an RCT, participants are randomly (by chance) assigned to one of two or more groups. One group receives the new treatment, and the other group receives the standard treatment. In this clinical trial type, the RCT tests if a new treatment or a standard treatment is more effective.

Clinical trials are essential for advancing medical knowledge and improving healthcare. These studies allow doctors to determine whether new treatments are safe and effective, providing vital information that leads to better care. By participating, you play a critical role in shaping the future of medicine, helping to bring new hope and improved treatments to patients now and in the years to come.

Participating in a clinical trial offers several potential benefits:

• Access to New Treatments – You may have an opportunity to receive cutting-edge treatment before it becomes widely available. This can be especially beneficial if current treatments for your condition are ineffective or have limited options.
• Contributing to Groundbreaking Medical Research – By participating in a clinical trial, you’re helping researchers develop improved treatments and healthcare options for future patients. Your participation makes a difference in advancing medical care.
• High-Quality Care – Clinical trials follow strict guidelines, and all participants are closely monitored to ensure their safety and report the effectiveness of the medical device being studied. You’ll receive excellent care, whether you receive the new treatment or not.
• Close Monitoring of Your Health – Clinical trials require frequent checkups and health assessments, so your health is monitored closely. This helps catch any changes in your condition right away, allowing for quick adjustments in care if needed.

If you decide to participate, the process generally includes:

1. Informed Consent – Before joining, your doctor will discuss the study’s purpose, procedures, and potential risks in detail so you can make an informed decision about whether to participate and sign a form acknowledging your consent to join.
2. Screening and Enrollment – After consenting, you’ll undergo a screening process to confirm you meet the trial’s eligibility criteria. This may involve medical tests and assessments to verify that the trial is suitable for you.
3. Randomization (If Applicable) and Treatment Protocol – In some studies, participants are randomly assigned (like flipping a coin) to receive either the new treatment or the standard one, ensuring unbiased results. Once assigned, you will receive a treatment plan that may include a variety of care options. Throughout the treatment phase, your healthcare team will monitor your progress and adjust as needed to best support your recovery.
4. Strict Health Monitoring – Throughout the trial, you’ll be closely monitored by a healthcare team to assess how the treatment is affecting your health. You’ll have regular checkups and may undergo tests to evaluate your response to the treatment.

As with any medical treatment, participating in a clinical trial involves potential risks, like side effects or the chance that the treatment may not work as expected. The research team will inform you of any known risks before you join. Your health and safety are the top priority, and all clinical trials include safety protocols to protect you throughout the process.

To decide if participating in a clinical trial is right for you, talk with your healthcare team about how it aligns with your diagnosis and treatment goals. Review the eligibility requirements, weigh the potential benefits and risks, and discuss your options with your doctor and loved ones. For more information, reach out to the study coordinators or your healthcare team. Making an informed decision is essential to your treatment journey.

• Why am I a good candidate for this trial?
• What treatments or interventions are being tested/will I receive?
• What are the chances I’ll receive the experimental treatment (if randomized)?
• Will I know if I am receiving the experimental treatment (if randomized)?
• How does this trial compare to the standard treatment for my condition?
• What are the potential risks and benefits?
• What can I expect during the trial, and how long will it last?
• How might this trial impact my daily life?
• Can I continue taking my regular medications during the trial?
• What happens if my condition worsens during the trial?
• Will I be able to leave the trial if I change my mind?
• How will my privacy and personal health information be protected?

GammaTile is FDA-cleared for malignant (cancerous) operable brain tumors, with ongoing clinical trials for the following brain tumor types to further support its effectiveness.

• Newly Diagnosed Brain Mets
• Recurrent Brain Mets
• Newly Diagnosed Glioblastoma
• All malignant (cancerous) operable brain tumors (GammaTile Registry)

Learn more about the ongoing GammaTile clinical trials for brain tumors.

If you’re considering participating in a clinical trial or want to learn more, talk with your doctor or reach out to the GammaTile’s Clinical Study Team. You’ll be able to ask any questions and gain a better understanding of whether a trial is right for you.

Learn more about ongoing GammaTile clinical trials for brain tumors. For additional information, please contact our GammaTile Clinical Study Team.