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Magnetic Resonance Study of Liver in Chemotherapy


N/A
21 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal Cancer

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Trial Information

Magnetic Resonance Study of Liver in Chemotherapy


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kristen Zakian, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-082

NCT ID:

NCT00578838

Start Date:

August 2006

Completion Date:

December 2013

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021