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

Not Applicable

Active, not recruiting

• Conditions: Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Resectable Colorectal Carcinoma; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Metastatic Malignant Neoplasm in the Liver
• Interventions: Procedure: Diffusion Weighted Imaging

• Registration Number: NCT04796818
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2020-08-12
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (IVIM DWI)	Diffusion Weighted Imaging	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging	Up to 3 months or 5 months (each cycle is 28 days)

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States