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Radiation Therapy
Image-Guided Radiosurgery for Brain Tumor (IG-SRS Trial)
Phase 2
Recruiting
Led By Jona Hattangadi-Gluth, MD
Research Sponsored by Jona Hattangadi-Gluth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment), 3 months and 6 months post-treatment
Awards & highlights
IG-SRS Trial Summary
This trial is testing new ways to map and target brain tumors during radiation treatment, in order to spare nearby healthy brain tissue and reduce cognitive side effects.
Who is the study for?
Adults over 18 with 1-3 small brain metastases from cancers like lung or breast, who can undergo MRI scans and have a life expectancy over 6 months. They must be able to perform daily activities with mild symptoms at most and participate in neurocognitive tests. Pregnant women, those unable to use contraception, or patients previously treated with whole brain radiation are excluded.Check my eligibility
What is being tested?
The trial is testing a precise radiosurgery technique that aims to spare cognitive function while targeting brain tumors. It uses advanced imaging methods to protect critical brain areas during treatment and assesses the effectiveness through biomarkers of radiation response.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of stereotactic radiosurgery include headaches, swelling, fatigue, hair loss at the treatment site, nausea, and short-term memory issues.
IG-SRS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-treatment), 3 months and 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment), 3 months and 6 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Attention/Processing Speed from baseline to 3 months after SRS
Change in Executive Functioning from baseline to 3 months after SRS
Change in Language functioning from baseline to 3 months after SRS
+1 moreSecondary outcome measures
Diagnostic Imaging
Longitudinal changes in imaging biomarker mean diffusivity (MD) from DTI imaging
Longitudinal changes in imaging biomarker volume from volumetric MR imaging
IG-SRS Trial Design
1Treatment groups
Experimental Treatment
Group I: Image-guided cognitive sparing brain SRSExperimental Treatment1 Intervention
This is a single arm phase II study where enrolled subjects will receive intracranial SRS will performed identically to standard of care, except for implementing additional imaging techniques and software for additional regional avoidance for cognitive sparing (specifically sparing white matter and the bilateral hippocampus)
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Who is running the clinical trial?
Jona Hattangadi-GluthLead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,528 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to undergo a magnetic resonance imaging (MRI) scan with a contrast dye.You have cancer that has spread from a specific type of tumor, and you are not eligible for a certain type of radiation treatment.You have one to three small brain tumors, each less than 3 cm in size.You are expected to live for at least 6 more months.The tumor is invading an important area of the brain that needs to be protected, such as a part that affects thinking and memory.You are scheduled to receive chemotherapy on the same day as SRS.You have received radiation therapy to the entire brain in the past.You have cancer that has spread to the covering of the brain and spinal cord, and you are not eligible for a specific type of radiation treatment.Your doctor has confirmed that you have cancer in a specific part of your body, like the lung, breast, or prostate.You are able to perform daily activities without being limited by symptoms.You can answer questions and follow instructions during brain function testing.
Research Study Groups:
This trial has the following groups:- Group 1: Image-guided cognitive sparing brain SRS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the FDA granting endorsement to Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)?
"Taking into account the Phase 2 status of Cognitive Sparing Brain Stereotactic Radiosurgery (SRS), our team at Power calculated its safety score to be a 2, indicating that there is some evidence for security but no existing data on efficacy."
Answered by AI
Are there any remaining opportunities to take part in this experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this trial is currently in search of its required sample size. It was first posted on May 1st 2019 and last modified on the 17th of May 2022; requiring 60 participants at a single site."
Answered by AI
What is the maximum capacity of participants for this clinical examination?
"Affirmative. According to clinicaltrials.gov, this research is currently enrolling participants with the trial having been published on May 1st 2019 and most recently edited on May 17th 2022. 60 individuals are being accepted across a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
What site did they apply to?
Moores Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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