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Investigational Scan for Colorectal Cancer

N/A

Waitlist Available

Led By Priya R Bhosale

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with at least 1 colorectal liver metastasis measuring at least 1 cm

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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).

Who is the study for?

This trial is for patients with colorectal cancer that has spread to the liver, who have at least one tumor of 1 cm or larger. They should be starting chemotherapy and able to follow up before and after surgery. It's not for those allergic to gadolinium, previously treated with certain therapies for their liver metastases, having pacemakers, or weighing over 400 pounds.

What is being tested?

The trial is testing a new imaging scan called Intravoxel Incoherent Motion Diffusion Weighted Imaging (IVIM DWI). This scan aims to measure how well colorectal cancer treatments are working in the liver by capturing changes in tumors before and after chemotherapy.

What are the potential side effects?

Since this trial involves an investigational imaging technique rather than a drug treatment, traditional side effects like you'd expect from medication aren't applicable. However, there may be risks associated with exposure to magnetic fields or contrast agents used during the scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a liver tumor from colorectal cancer that is at least 1 cm big.

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I am about to start chemotherapy for liver metastases from colon cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or will have treatments like chemotherapy or radiation for liver metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months or 5 months (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in the true diffusion coefficient (D)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (IVIM DWI)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diffusion Weighted Imaging

2006

Completed Phase 2

~150

0 / 3Eligibility criteria met