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Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors


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Open (Enrolling)
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Kidney Neoplasms

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Trial Information

Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors


"3 Tesla" MRI is a new MRI scanner that in theory, can produce better images than currently
available MRI scanners.

Currently, CT scanning is the main way of evaluating tumors in the kidneys. However, there
are some patients who cannot have CT scans (usually, because of allergy to CT contrast
medium or kidney damage/failure). It is with these patients that researchers are hoping to
use a technique (using MRI) that is as good as CT scanning.

As part of your standard of care, your doctor is requesting a CT scan of your kidneys and
abdomen. If you take part in this study, you will have a "3 Tesla" MRI scan of your kidneys
and abdomen as well, within 15 days following your routine CT.

For the "3 Tesla" MRI scan, you will be lying flat on the MRI scanner, and as with a regular
scan, you will have a small needle placed in a vein in your arm to inject the contrast dye.
A diuretic, Lasix, will be given to help distend the internal tubes in the kidney to help
view your kidney better. The MRI scan will take between 1-2 hours to perform. As with
regular scans, you may be asked to hold your breath on occasions.

If there is a concern about your kidney function, blood (about 1 teaspoon) will be drawn to
test your kidney function before you have the MRI.

Your participation in the study will be complete at the end of the MRI scan. The routine CT
scan will be the main decision making examination. However, if the MRI shows something
different and potentially relevant to your care, your referring physician will be informed.

This is an investigational study. A total of 45 patients will take part in this study. All
will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients who have undergone or are due to undergo a CT Renal Protocol study, in the
course of pre-operative evaluation for renal tumor surgery.

2. Written informed consent will be obtained.

Exclusion Criteria:

1. Patients with an allergy to both gadopentetate dimeglumine and gadodiamide MRI
contrast agents.

2. Patients with certain metallic implants, e.g., cardiac pacemakers, cardiac
defibrillators, aneurysm clips, neurostimulators, and certain metallic foreign
bodies. Implanted medical devices must be MRI compatible at 3.0 Tesla field
strengths.

3. Patients with claustrophobia, or requiring sedation for the MRI scan.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Comparison of CT and MRI scans of patients with renal cell carcinoma in evaluating each of nine imaging variables.

Outcome Time Frame:

4 Years

Safety Issue:

No

Principal Investigator

Chaan Ng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0875

NCT ID:

NCT00507884

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Kidney Neoplasms
  • Kidney Neoplasms
  • Renal Tumors
  • Magnetic Resonance Imaging
  • 3 Tesla MRI
  • MRI
  • Neoplasms
  • Kidney Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030