Overview

This trial is active, not recruiting.

Conditions colon cancer, rectal cancer
Treatments magnetic resonance
Sponsor Memorial Sloan Kettering Cancer Center
Start date August 2006
End date December 2017
Trial size 55 participants
Trial identifier NCT00578838, 06-082

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
25 patients with metastatic colorectal cancer. 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.
magnetic resonance
Patients each will undergo 4 MR examinations as part of this research study.
25 patients with non-metastatic colorectal cancer. 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.
magnetic resonance
Patients each will undergo 4 MR examinations as part of this research study.
11 healthy volunteers, who will also undergo two scans 2-3 weeks apart.
magnetic resonance
You will have two MR exams on two different days. There will be no injection of contrast material. An MR exam requires about 1 hour. The second MR exam will take place 2-3 weeks after the first one. This second MR exam will take about 1 hour and will look at whether the results from the MR exams are reliable and repeatable.

Primary Outcomes

Measure
To determine whether magnetic resonance techniques can detect changes in normal liver morphology and metabolism caused by chemotherapy in patients with colorectal cancer.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title Magnetic Resonance Study of Liver in Chemotherapy
Principal investigator Kristen Zakian, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.