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Investigational Scan for Colorectal Cancer

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change in the true diffusion coefficient (D)

Secondary outcome measures

Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,267 Total Patients Enrolled

Priya R BhosalePrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

20,044 Total Patients Enrolled

Media Library

Diffusion Weighted Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04796818 — N/A

Colorectal Cancer Clinical Trial 2023: Diffusion Weighted Imaging Highlights & Side Effects. Trial Name: NCT04796818 — N/A

Diffusion Weighted Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04796818 — N/A

Colorectal Cancer Research Study Groups: Diagnostic (IVIM DWI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are engaging in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial initially posted on 8/12/2020 is actively recruiting participants. The research requires 50 patients from a single medical centre in order to move forward with their investigations."

Answered by AI

Are there currently openings for individuals to join this research project?

"Affirmative. According to clinicaltrials.gov, this medical study is currently enrolling participants. This experiment was initially uploaded on August 12th 2020 and has been revised since then as recently as July 15th 2022. There are spaces for 50 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04796818.

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