Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 6:13 PM
Study NCT ID:
NCT02277561
Status:
WITHDRAWN
Last Update Posted:
2020-03-04
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging
Status:
WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB approved but never implemented
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.
OUTLINE:
Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.
I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.
OUTLINE:
Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01015 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 13-01-047 | OTHER | Albert Einstein College of Medicine | View | |
| P30CA013330 | NIH | None | https://reporter.nih.gov/quic… | View |