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NCT Number: NCT04796818

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Priya R. Bhosale

CONTACT

713-792-0221

Priya R. Bhosale

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion Weighted Imaging

Procedure

Undergo IVIM DWI

Other names: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DW-MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Primary outcomes

  1. Absolute change in the true diffusion coefficient (D)

    Time frame: 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 outcomes

  1. Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging

    Time frame: Up to 3 months or 5 months (each cycle is 28 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Priya R Bhosale

CONTACT

[email protected]

713-792-0221

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2021
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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