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Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507884
  Purpose

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.


Condition Intervention
Kidney Neoplasms
Procedure: 3 Tesla MRI Scan

MedlinePlus related topics: Cancer Kidney Cancer MRI Scans Nuclear Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find out if "3 Tesla" MRI is as good as CT scan in the evaluation of kidney tumor(s). [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 45
Study Start Date: March 2005
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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 45 minutes.

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 about 45 minutes. As with regular scans, you may be asked to hold your breath on occasions.

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. "3 Tesla" MRI scans are commercially available. A total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507884

Contacts
Contact: Chaan Ng, MD 713-792-6759

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Chaan Ng, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Chaan Ng, MD U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Chaan Ng, MD/Associate Professor )
Study ID Numbers: 2004-0875
Study First Received: July 26, 2007
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00507884  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Urologic Diseases
Kidney Neoplasms
Urogenital Neoplasms
Renal cancer
Kidney Diseases
Kidney cancer
Urologic Neoplasms
Urinary tract neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009