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

ConditionsMetastatic 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Diffusion Weighted Imaging
Procedure/Surgery
Undergo IVIM DWI

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: Diagnostic (IVIM DWI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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