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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:1/24/2018
Start Date:March 2005
End Date:March 2019

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The goal of this clinical research study is to find out if "3 Tesla" MRI is as good as CT
scan in the evaluation of kidney tumor(s).

Objectives:

To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla
for evaluation of renal tumors and their vascular supply, which can be adopted in patients
who are unable to undergo CT evaluation.

"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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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