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 (Other)

Overall Status

Recruiting

CT.gov ID

NCT04796818

Collaborator

(none)

Enrollment

Location

Arm

41.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Diffusion Weighted Imaging	N/A

Detailed Description

PRIMARY OBJECTIVE:

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:

Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 12, 2020

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic (IVIM DWI) 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 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

Arm

Intervention/Treatment

Experimental: Diagnostic (IVIM DWI)

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Priya R Bhosale, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

MD Anderson Cancer Center Website

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT04796818

Other Study ID Numbers:

2020-0004
NCI-2020-07466
2020-0004

First Posted:

Mar 15, 2021

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carcinoma

Colorectal Neoplasms

Neoplasms

Study Results

No Results Posted as of Jul 18, 2022