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MRI for Brain Tumor Detection After Radiation

N/A

Recruiting

Led By Ayal Aizer, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be age 18 years or older

Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months of study enrollment

Awards & highlights

Study Summary

This trial is studying whether an MRI can show if a brain tumor has come back after treatment with radiation.

Who is the study for?

This trial is for adults with confirmed extracranial solid malignancies and brain metastases previously treated with focused radiation. They must be planning neurosurgical resection as standard care, agree to use contraception, and be able to consent. Excluded are those with severe kidney disease, gadolinium allergy, pregnancy, breastfeeding or MRI contraindications.Check my eligibility

What is being tested?

The study tests a specialized MRI technique to distinguish between tumor recurrence and radiation changes in the brain after stereotactic radiation therapy for brain metastases. Participants will undergo this imaging method before planned surgical removal of the lesion.See study design

What are the potential side effects?

While MRIs are generally safe and non-invasive, potential side effects include discomfort from lying still during the procedure or reactions in those allergic to contrast agents used (gadolinium), though such individuals are excluded from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have cancer that started outside the brain but now has spread to the brain, and I've had radiation for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 months of study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 months of study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity

Secondary outcome measures

Negative predictive value

Positive predictive value

Specificity

Trial Design

1Treatment groups

Experimental Treatment

Group I: TRAMs IExperimental Treatment1 Intervention

Magnetic resonance imaging (MRI)-based treatment response assessment maps (TRAMs) Patients with an enlarging lesion in the site of a brain metastasis treated with stereotactic radiation for which neurosurgical resection is planned will undergo preoperative TRAMs

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~1370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,933 Total Patients Enrolled

Ayal Aizer, MDPrincipal Investigator - Dana-Farber Cancer Institute

Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute

Yale University School Of Medicine (Medical School)

Media Library

MRI Clinical Trial Eligibility Overview. Trial Name: NCT04033497 — N/A

Brain Tumor Research Study Groups: TRAMs I

Brain Tumor Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT04033497 — N/A

MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04033497 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment open at the moment?

"Correct. The information hosted on clinicaltrials.gov suggests that this health study, which was initially made available on August 20th 2019, is actively enrolling subjects. A total of 53 participants must be recruited from 1 medical facility."

Answered by AI

What is the current enrollment size for this clinical research program?

"That is correct. According to the clinicaltrials.gov registry, this study which first appeared on August 20th 2019, still recruiting patients and has enrolled 53 individuals from a single site thus far."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

Ayal Aizer, MD 2019. "Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04033497.

All > Brain Metastases