Treatment response assessment maps (TRAMs) in the delineation of radiation necrosis from tumor progression after stereotactic radiation in patients with brain metastases: A prospective study

This research study is investigating the value of an imaging study of the brain called an MRI
(which stands for magnetic resonance imaging), utilized in unique way, to delineate whether
the tumor has recurred or whether radiation changes have occurred after a brain metastasis
treated with focused radiation has enlarged.

Inclusion Criteria:

- 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. Patients with intracranial
pathologic confirmation of a malignancy which originated extracranially but for which
extracranial disease has not been biopsied are eligible.

- Participants must have an enlarging lesion in the brain at least 4 months after prior
stereotactic radiation to the same site for which neurosurgical resection is planned
as routine standard of care.

- Participants must be age 18 years or older.

- Participants must be willing to undergo study procedures.

- The effects of gadolinium / other MRI-based contrast agents on the developing human
fetus are unknown. For this reason, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation. Should a
woman become pregnant or suspect she is pregnant while she is participating in this
study, she should inform her treating physician immediately.

- Participants must possess the ability to understand and the willingness to sign a
written informed consent document.

Exclusion Criteria:

- Participants who have a contraindication to MRI (e.g. non compatible implanted
metallic device for which MRI is absolutely contraindicated).

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

- Participants with a history of anaphylactic reactions to gadolinium.

- Pregnant women are excluded from this study because gadolinium-based agents have not
been proven to be safe to administer to a developing fetus. Similarly, breastfeeding
women will be excluded from this study.