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NCT00285324 · ClinicalTrials.gov registry record

Diffusion Tensor MRI to Distinguish Brain Tumor Recurrence From Radiation Necrosis

A clinical trial of Primary Brain Tumor and Radiation Necrosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
29
Enrollment target
1
Study location

NCT00285324: Completed study of Primary Brain Tumor and Radiation Necrosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00285324 is a study of Primary Brain Tumor and Radiation Necrosis that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 29 participants, below the 82-participant average among 7 other Primary Brain Tumor trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00285324, a study of Primary Brain Tumor and Radiation Necrosis, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
29 participants
Enrollment target
1
Study location

Study Summary

This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI) for distinguishing injured brain tissue due to radiation therapy (radiation necrosis) from the return of a brain tumor that was previously removed (tumor recurrence). DT-MRI differs from standard MRI in the way that computers process the images; there is no difference in the experience of having the procedure done. Both radiation necrosis and tumor recurrence can occur within weeks to months following brain radiation treatment. Because the treatment and management options for the two conditions differ significantly, distinguishing the two is of critical importance. Currently, surgical biopsy is required to make this differentiation. Healthy volunteers and patients who have received radiation therapy as part of their treatment for a brain tumor may be eligible for this study. All candidates must be at least 21 years old. Patients must have a new area of abnormality that requires a biopsy to determine whether it is a tumor recurrence or radiation necrosis. Candidates are screened with a medical history and physical examination. In addition, patients have blood and urine tests. All participants undergo MRI and DT-MRI. MRI uses a strong magnetic field and radio waves instead of X-rays to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder and wears earplugs to muffle loud knocking noises that occur during the scanning. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 40-60 minutes. Subjects may be asked to lie still for up to 20 minutes at a time. DT-MRI is a type of MRI that measures how water moves in the brain tissue. This technique uses the same MRI machine as conventional MRI, but the diffusion images are obtained after the normal MRI scan, and by a computer progra

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2006-01-27
Est. Completion 2013-08-20

What the finished NCT00285324 record still lists

NCT00285324 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 82-participant average among 7 other Primary Brain Tumor trials with a reported enrollment target (65% lower).

The record links to 3 conditions, with Primary Brain Tumor appearing as the primary indexed condition, and to 0 interventions.

NCT00285324 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00285324 about?

NCT00285324 is a clinical study titled "Diffusion Tensor MRI to Distinguish Brain Tumor Recurrence From Radiation Necrosis". This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI) for distinguishing injured brain tissue due to radiation therapy (radiation necrosis) from the return of a brain tumor that was previously removed (tumor recurrence). DT-M...

What is the current status of trial NCT00285324?

This trial is currently completed. The enrollment target is 29 participants. The study started on 2006-01-27. Estimated completion is 2013-08-20.

What conditions does trial NCT00285324 study?

This clinical trial studies the following conditions: Primary Brain Tumor, Radiation Necrosis, Glioma Tumor Recurrence.

Who is sponsoring clinical trial NCT00285324?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00285324 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00285324, the US trial registry maintained by the National Library of Medicine. NCT00285324 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.