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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

Must not have

Participants who have chronic kidney disease stage IV-V or end stage renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months of study enrollment

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have advanced chronic kidney disease or am in end stage renal failure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity

Secondary study objectives

Negative predictive value

Positive predictive value

Specificity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2810

0 / 3Eligibility criteria met