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Protocol No. UW13044

Principal Investigator Kim, David

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Loco-regional lymph node staging assessment by gadofosveset trisodium-enhanced FDG18PET/MR in newly diagnosed colon cancer

Objective The purpose of the research is to see if we can use combined Positron Emission Tomography (PET) Magnetic Resonance (MRI) images to help us determine lymph node involvement in colorectal cancer.

Treatment Participation in this study involves a single visit to University of Wisconsin Hospital and Clinics (UWHC) or the Wisconsin Institutes for Medical Research (WIMR) to perform some imaging no more than 30 days prior to your scheduled surgery.

Description For rectal cancer patients, the patient will either administer two Fleets enemas at home or have them administered upon arrival in the Department in order to empty the last part of your bowel. A fleets enema will not be needed for colon cancer patients but instead, a small amount of air will be introduced into your colon just prior to the imaging procedure. Patients will be asked to drink a contrast agent prior to the exam. An IV will be used to inject a tracer for the PET/MR scan. It takes just under an hour for the tracer to get to the abdominal cavity, including the colon. The patient will then lie quietly inside the center of the PET/MRI machine for up to 60 minutes. In the clinical pathology lab photographs of the tissue that is removed from the colon will be taken so that we can document how the tissue and lymph nodes are oriented to each other.

Key Eligibility
  • Newly diagnosed colorectal cancer proven by biopsy at the time of colonoscopy
  • Age 18-85 years
  • Able to undergo PET/MR evaluation (no contraindications)
  • Patients not eligible if they have a prior surgical resection for GI oncologic condition
  • Patients not eligible if they hae a known diagnosis of Inflammatory Bowel Disease (IBD)
  • Patients not eligible if they have a known diagnosis of Inflammatory Bowel Disease (IBD)
  • Women are not eligible if pregnant or breastfeeding

Applicable Disease Sites Colon and Rectum

Therapies Involved Other

Drugs Involved Ablavar (Gadofosveset trisodium); Gadofosveset trisodium

Status Open

Participating Institutions UW Hospital and Clinics