Clinical trial · Interventional
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
NCT02311556CI-TRIAL-00026144completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.
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 Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DSC-PMR
- description
- DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery
- interventionNames
- Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Primary outcomes (1)
- measure
- Time to local progression of each treated and evaluable brain metastasis
- timeFrame
- At time of radiosurgery and after radiosurgery (approximately 1 week)
- description
- Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
Secondary outcomes (4)
- measure
- Radiation necrosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic. * At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR. * Patient must be clinically eligible for and elect to be treated with GK alone without WBRT. * Patient must be ≥ 18 years of age. * Patient must have Karnofsky Performance Status (KPS) of at least 60 * Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies. * Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis). * Patient must not be pregnant or breastfeeding. * Patient must not have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2. * Patient must not have melanoma. * Patient must not have hemorrhagic lesions.
References
Publications (0)
Data not yet available
No reference posted for this study.