Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT00820456
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2009-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI
Sponsor:
American College of Radiology
Organization:
Study Overview
Official Title:
Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not meet enrollment goals.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives for this study include:
* Testing a unique way of imaging people with colorectal cancer and other cancers that has spread to the liver using magnetic resonance imaging (MRI);
* Seeing if the MRI process can be used across multiple imaging platforms;
* Determining whether the results of the imaging can be reproduced;
* Reviewing how MRI results relate to cancer response to combination therapy and to clinical endpoints.
* Testing a unique way of imaging people with colorectal cancer and other cancers that has spread to the liver using magnetic resonance imaging (MRI);
* Seeing if the MRI process can be used across multiple imaging platforms;
* Determining whether the results of the imaging can be reproduced;
* Reviewing how MRI results relate to cancer response to combination therapy and to clinical endpoints.
Detailed Description:
This study will investigate the use of projection reconstruction dynamic contrast-enhanced MRI (DCE-MRI) as a surrogate marker of tumor vascularity in patients treated with the antiangiogenic agent bevacizumab. DCE-MRI is gaining popularity as a method to assess the functional response of tumors to agents targeting the vascular endothelial growth factor (VGEF) pathways. DCE-MRI measurements have been proposed as a non-invasive measure of both tumor biologic activity and (in the case of antivascular therapy) early response to treatment. A number of phase I and II studies demonstrate the ability for DCE-MRI to detect perfusion changes associated with tumor biologic response to vascularly targeted agents. It has been suggested that pre-treatment DCE-MRI might identify tumors with high intrinsic perfusion and that these tumors will be more likely to respond to antivascular-based therapies. However, the current use of DCE-MRI in clinical settings is challenging. Trade-offs between spatial coverage, time, and spatial resolution make this technique difficult to implement in human studies and may limit its reliability. The use of projection reconstruction-based acquisition can mitigate the need for these trade-offs and can simultaneously provide high temporal and spatial resolution data for DCE-MRI analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| SAP #4100031303 | None | None | View |