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WithdrawnNCT00229801Updated Sep 24, 2012

Evaluation of Kidney Function in Children With Brain Tumors

An interventional study of MRI in Brain Tumor, sponsored by Children's Healthcare of Atlanta. Withdrawn at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2012-09-24.

Sponsored by Children's Healthcare of Atlanta · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
No funds available, hard to enroll patients-Terminated in 2008
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
Up to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Brain Tumor

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Keywords

  • Renal Function, MRI
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

Browse Brain Neoplasms studies →

Lead sponsor

Children's Healthcare of Atlanta is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    MRI

    Radiation: MRI

Interventions

  • RadiationMRI
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Study locations

1 site
  • Children's Healthcare of Atlanta at Scottish Rite
    Atlanta, Georgia 30342, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00229801
Lead sponsor
Children's Healthcare of Atlanta
First posted
Sep 30, 2005
Start date
Jun 2004
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Sep 24, 2012

Study contacts

Damien Grattan-Smith, MBBS
principal investigator · Children's Diagnostic Imaging of Atlanta/Children's Healthcare of Atlanta
Richard Jones, PhD
principal investigator · Emory University/Children's Healthcare of Atlanta
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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