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Evaluation of Kidney Function in Children With Brain Tumors

Primary Purpose

Brain Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Children's Healthcare of Atlanta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Renal Function, MRI

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All children currently enrolled, and who will be enrolled during the course of the study, in the chemotheraphy program at Children's Healthcare of Atlanta at Scottish Rite Exclusion Criteria: -

Sites / Locations

  • Children's Healthcare of Atlanta at Scottish Rite

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

MRI

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 20, 2012
Sponsor
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT00229801
Brief Title
Evaluation of Kidney Function in Children With Brain Tumors
Official Title
Evaluation of Renal Function in Children With Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No funds available, hard to enroll patients-Terminated in 2008
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Healthcare of Atlanta

4. Oversight

5. Study Description

Brief Summary
Clinical measurement of renal function is generally performed using either laboratory tests or nuclear medicine techniques, however, both of these techniques suffer from some limitations. Notably the lab tests only assess global, rather than individual kidney, function and the nuclear medicine tests are demanding to perform well. Children with brain tumors are often treated with chemotherapeutic in order to try and kill the cancer. Amongst the known side effect of some of the drugs used in the chemotherapy is the fact that they may damage the kidneys. For this reason the function of the kidneys is assessed using a laboratory test at 3 or 6 months intervals during the treatment. In addition, to the problem mentioned above the tests also require a separate visit to the hospital. Children with brain tumors who are undergoing chemotherapy also routinely have contrast-enhanced MRI of the brain performed at intervals of three months in order to evaluate the response of the tumor to the chemotherapy. Recently, MRI techniques have been developed which can evaluate single kidney renal function. The aim of this study is to establish if a single MRI exam can be used to assess both the effect of the chemotherapy on both the tumor and the renal function. The results of the MRI measurement of the single kidney renal function would be combined to provide a measure of global renal function and this would be compared with that obtained from the laboratory test. The MRI exam will require only require an extra 10 minutes of scanning time and will not affect the rest of the MRI exam in any way. This study is being performed to validate a new technique for measuring kidney function. Patients are being asked to volunteer for this study because they require serial contrast enhanced MR scans to monitor their response to chemotherapy. Because some chemo-therapeutic agents can be toxic to the kidney the patient's kidney function will also be evaluated using conventional methods, and the results of these tests can be compared to those obtained using MRI. We plan to study 50 children in this study. The additional procedure for measuring renal function will add 10 minutes to the duration of the MRI exam and will have no effect on the routine brain study. If validated the proposed MRI technique would allow renal function to be evaluated at the time of a routine, contrast enhanced MRI exam and would avoid additional testing using radioactive tracers or urine collection over 24 hours. If successful, MRI could be used to measure single kidney renal function in all any patient undergoing a routine MRI exam by simply extending the scanning time by a maximum of 10 minutes. This would save such patients additional visits to the hospital and would have the advantage of measuring single kidney, rather than global, renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Renal Function, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
MRI

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children currently enrolled, and who will be enrolled during the course of the study, in the chemotheraphy program at Children's Healthcare of Atlanta at Scottish Rite Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien Grattan-Smith, MBBS
Organizational Affiliation
Children's Diagnostic Imaging of Atlanta/Children's Healthcare of Atlanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Jones, PhD
Organizational Affiliation
Emory University/Children's Healthcare of Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta at Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

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Evaluation of Kidney Function in Children With Brain Tumors

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