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NCT Number: NCT00578838

Magnetic Resonance Study of Liver in Chemotherapy

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance

Other

Patients each will undergo 4 MR examinations as part of this research study.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2007
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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