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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Treatment	Active	21 and over	Other	06-082 R03 CA119756-01, NCT00578838

Trial Description

Summary

The purpose of this study is to see whether magnetic resonance (MR) techniques can detect changes caused by chemotherapy in the livers of patients who have been treated for colorectal cancer. Some patients who undergo chemotherapy for colorectal cancer may experience side-effects in their livers.

These side effects may influence further treatment options. If this study finds that MR techniques detect changes in the liver due to chemotherapy, then MR methods may eventually be used to help patients and physicians plan further treatment.

Further Study Information

Each patient will have 4 MR exams: prior to or within one week of the start of the chemotherapy regimen, one after 6 weeks of chemotherapy, a third after completion of chemotherapy (between 12 and 24 weeks post-initiation of chemotherapy) and a long term followup study at least 4 months after the completion of chemotherapy. Normal volunteers will be recruited and studied by MR for comparison to patient data.

Primary aim is to determine whether magnetic resonance techniques can detect changes in normal liver morphology and metabolism caused by chemotherapy in patients with colorectal cancer.

Eligibility Criteria

Inclusion Criteria:

• Provide written informed consent.

• 21 years of age or older.

• Histologically confirmed diagnosis of colorectal carcinoma (patients only).

• Resected primary colorectal cancer and no metastatic disease or primary colorectal cancer with no metastatic disease and planned resection after neo-adjuvant chemotherapy or metastatic colorectal carcinoma considered by the attending physician to have resectable or potentially resectable hepatic metastases (patients only). Each patient will be staged by his/her attending physician in the Department of Medicine or Surgery. Hepatic metastases are considered resectable if they are expected to be completely removable with negative margins by a procedure that leaves behind sufficient liver parenchyma with arterial/portal blood supply, venous drainage and biliary drainage for subsequent regeneration and survival. Potentially resectable indicates that a reduction in tumor size due to chemotherapy could render the tumors resectable.

Exclusion Criteria:

• Inability to cooperate for an MR exam.

• Contraindication to MR:

• Pacemaker

• Aneurysmal clips

• Any ferrous metallic implants which could be deflected by the magnet

• Metal implants in field of view which could distort the images and spectroscopy data

• Pregnant women

• Age and mental status wherein he/she is unable to cooperate for MR study

• Patients who are considered to have unresectable hepatic metastases will be excluded. Hepatic metastases are considered unresectable if their removal would leave behind insufficient liver parenchyma for subsequent regeneration and survival. In addition, hepatic metastases are considered unresectable if their removal would be expected to leave behind residual disease (positive margins). Also, patients are considered unresectable if they have any comorbid conditions which would jeopardize successful recovery from hepatic resection.

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Kristen Zakian, PhD

Principal Investigator

Kristen Zakian, PhD
		Email: zakiank@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Kristen Zakian, PhD
			Email: zakiank@mskcc.org

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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00578838
Information obtained from ClinicalTrials.gov on May 13, 2009