Clinical trial · Interventional
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TRAMs I
- description
- * 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
- interventionNames
- Device: MRI
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- Within 3 months of study enrollment
- description
- The sensitivity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review
Secondary outcomes (3)
- measure
- Specificity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 via ink on paper or via an electronic signature medium such as Adobe Sign. 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.
References
Publications (0)
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