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NCT04796818 Clinical Trial

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

Stage IV Colorectal Cancer AJCC v8 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04796818
Other study ID # 2020-0004
Secondary ID NCI-2020-0746620
Status Recruiting
Phase N/A
First received
Last updated
Start date August 12, 2020
Est. completion date January 31, 2026

Study information
Verified date January 2024
Source M.D. Anderson Cancer Center
Contact Priya R Bhosale
Phone 713-792-0221
Email priya.bhosale@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 31, 2026
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Diffusion Weighted Imaging
Undergo IVIM DWI

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging Up to 3 months or 5 months (each cycle is 28 days)
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