An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging

Conditions
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Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8

Intervention / Treatment
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* Procedure: Diffusion Weighted Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)/leucovorin (FOLFOX), irinotecan with 5-FU/leucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent Patients with at least 1 colorectal liver metastasis measuring at least 1 cm Patients with anticipated follow-up before and after surgery at MD Anderson Exclusion Criteria: Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver Patients allergic to gadolinium Patients with pacemakers Greater than 400 pounds in weight

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (IVIM DWI)<br>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. | Procedure: Diffusion Weighted Imaging<br>* Undergo IVIM DWI<br>* Other names: MR Diffusion-Weighted Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in the true diffusion coefficient (D) | The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test. | Up to 3 months or 5 months (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging |  | Up to 3 months or 5 months (each cycle is 28 days) |