NCT00507884

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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

17.5 years

First QC Date

July 26, 2007

Last Update Submit

December 29, 2020

Conditions

Keywords

Kidney NeoplasmsRenal TumorsMagnetic Resonance Imaging3 Tesla MRIMRI

Outcome Measures

Primary Outcomes (1)

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

    4 Years

Study Arms (1)

3 Tesla MRI

Patients with renal tumors scheduled to have a CT scan of the kidneys and abdomen.

Procedure: 3 Tesla MRI Scan

Interventions

MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours.

3 Tesla MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants with renal tumors scheduled to have a CT scan of the kidneys and abdomen.

You may qualify if:

  • 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.
  • Written informed consent will be obtained.

You may not qualify if:

  • Patients with an allergy to both gadopentetate dimeglumine and gadodiamide MRI contrast agents.
  • 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.
  • Patients with claustrophobia, or requiring sedation for the MRI scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Chaan Ng, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

March 1, 2005

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations