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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507884
Recruitment Status : Active, not recruiting
First Posted : July 27, 2007
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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).


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.

Condition or disease Intervention/treatment
Kidney Neoplasms Procedure: 3 Tesla MRI Scan

Detailed Description:

"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.

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors
Actual Study Start Date : March 2005
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
3 Tesla MRI
Patients with renal tumors scheduled to have a CT scan of the kidneys and abdomen.
Procedure: 3 Tesla MRI Scan
MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours.

Primary Outcome Measures :
  1. Comparison of CT and MRI scans of patients with renal cell carcinoma in evaluating each of nine imaging variables. [ Time Frame: 4 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants with renal tumors scheduled to have a CT scan of the kidneys and abdomen.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507884

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Chaan Ng, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00507884     History of Changes
Other Study ID Numbers: 2004-0875
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by M.D. Anderson Cancer Center:
Kidney Neoplasms
Renal Tumors
Magnetic Resonance Imaging
3 Tesla MRI

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases