Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03698162
Status:
TERMINATED
Last Update Posted:
2024-01-09
First Post:
2018-10-01
Brief Title:
Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Area B Precise DCE-MRI Assessment of Brain Tumors
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dynamic contrast-enhanced DCE magnetic resonance imaging MRI is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain The specially-tailored acquisition and reconstruction STAR DCE MRI could provide improved assessment of brain tumor status and response to therapy
Detailed Description:
PRIMARY OBJECTIVES
I To optimize and technically validate specially-tailored acquisition and reconstruction STAR DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic TK parameter maps
SECONDARY OBJECTIVES
I To develop a robust clinical implementation of STAR DCE-MRI II To clinically evaluate STAR DCE-MRI in patients with brain tumors
OUTLINE Participants are assigned to 1 of 2 cohorts
COHORT I Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months and just prior to and 4-6 weeks after starting bevacizumab treatment If there is concern for tumor progression ie increased contrast enhancement more frequent MRI scans will be scheduled
COHORT II Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy Participants may undergo more frequent MRI if there is concern for tumor progression
I To optimize and technically validate specially-tailored acquisition and reconstruction STAR DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic TK parameter maps
SECONDARY OBJECTIVES
I To develop a robust clinical implementation of STAR DCE-MRI II To clinically evaluate STAR DCE-MRI in patients with brain tumors
OUTLINE Participants are assigned to 1 of 2 cohorts
COHORT I Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months and just prior to and 4-6 weeks after starting bevacizumab treatment If there is concern for tumor progression ie increased contrast enhancement more frequent MRI scans will be scheduled
COHORT II Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy Participants may undergo more frequent MRI if there is concern for tumor progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-01890 | REGISTRY | None | None |
| 6B-17-2 | OTHER | None | None |
| P30CA014089 | NIH | None | None |
| R33CA225400 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchR33CA225400 |