Clinical trial · Interventional
Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery
Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB approved but never implemented
Summary
Brief summary (as posted)
This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors Metastatic to Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| diffusion tensor imaging | Procedure | — | UNRESOLVED |
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| whole-brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (VB-DTI, MRI)
- description
- Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
- interventionNames
- Procedure: diffusion tensor imaging
- Radiation: whole-brain radiation therapy
- Radiation: stereotactic radiosurgery
- Procedure: contrast-enhanced magnetic resonance imaging
- Procedure: diffusion-weighted magnetic resonance imaging
Primary outcomes (4)
- measure
- Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion
- timeFrame
- Up to 3 years
- measure
- Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with multiple lesions from solid tumors on clinical MRI diagnosing the brain metastases may be treated with either WBRT or SRS if clinically indicated at the time of presentation but not both * Karnofsky performance status (KPS) \>= 70 * Patients presenting with brain metastases from a newly diagnosed cancer may have systemic disease (brain disease at the time of initial cancer diagnosis) * Patients with a history of cancer, but newly diagnosed brain metastases must have clinically stable systemic disease * If a biopsy is performed, the patient has to be at least 1 week post-biopsy * The patient must be able to commit to diffusion-weighted magnetic resonance (MR) imaging, diffusion tensor imaging (DTI), and chemical shift imaging (CSI) prior to treatment, after the first week of treatment, and 7-11 days after the completion of treatment at the Magnetic Resonance Research Center (MRRC) * Patients undergoing SRS without WBRT must be able to commit to diffusion-weighted MR imaging, DTI, and CSI prior to treatment, and 7-11 days after the completion of the SRS treatment at the MRRC * The patient must also be able to commit to post-treatment follow-up visits at Montefiore Medical Center involving serial MR imaging; the follow-up visits are to occur bimonthly for 6 months and then every 6 months until death Exclusion Criteria: * Any medical condition, which would make the imaging studies or WBRT unsafe or poorly tolerated * Patient is receiving concurrent chemotherapy * Known allergic reaction to contrast or shellfish * Patients with brain metastases to be treated with radiosurgery * Patients with brain metastasis resulting from hematologic malignancies and small cell lung cancer * Implanted metal devices or foreign bodies that serve as a contraindication to MR imaging * Creatinine \> 1.4 mg/dl and creatinine clearance \< 20 mg/dl * Uncontrolled, clinically significant cardiac arrhythmias * Severe claustrophobia * Pregnant female * Any prior radiation therapy to the brain * KPS \< 70 * Patients with leptomeningeal disease
References
Publications (0)
Data not yet available