Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04796818
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.
SECONDARY OBJECTIVES:
I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.
II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.
OUTLINE:
Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.
I. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.
SECONDARY OBJECTIVES:
I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.
II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.
OUTLINE:
Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: