Glioblastoma Clinical Trial
Official title:
Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
Verified date | September 11, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is
threefold: 1) to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge
of the course of central nervous system tumors and identify areas that need further research;
2) to inform participants of new studies at the National Cancer Institute and other centers
as they are developed; and 3) to provide patients consultation on possible treatment options.
Children (at least 1 year old) and adults with primary malignant brain and spinal cord tumors
may be eligible for this study. Participants will have a medical history, physical and
neurological examinations and routine blood tests. They may also undergo one or more of the
following procedures:
- Magnetic resonance imaging (MRI) MRI is a diagnostic tool that uses a strong magnetic
field and radio waves instead of X-rays to show detailed changes in brain structure and
chemistry. For the procedure, the patient lies on a table in a narrow cylinder
containing a magnetic field. A contrast material called gadolinium may be used (injected
into a vein) to enhance the images. The procedure takes about an hour, and the patient
can speak with a staff member via an intercom system at all times.
- Computed axial tomography (CAT or CT) CT is a specialized form of X-ray imaging that
produces 3-dimensional images of the brain in sections. The scanner is a ring device
that surrounds the patient and contains a moveable X-ray source. The scan takes about 30
minutes and may be done with or without the use of a contrast dye.
- Positron emission tomography (PET) PET is a diagnostic test that is based on differences
in how cells take up and use glucose (sugar), one of the body s main fuels. The patient
is given an injection of radioactive glucose. A special camera surrounding the patient
detects the radiation emitted by the radioactive material and produces images that show
how much glucose is being used by various tissues. Fast-growing cells, such as tumors,
take up and use more glucose than normal cells do, and therefore, the scan might
indicate the overall activity or aggressiveness of the tumor. The procedure takes about
an hour.
When all the tests are completed, the physician will discuss the results and potential
treatment options with the patient. Follow-up will vary according to the individual. Some
patients may end the study with just one visit to NIH, while others may be followed at NIH
regularly, in conjunction with their local physicians. Patients with aggressive tumors may be
seen every 3 or 4 months, while those with less active tumors may be seen every 6 to 12
months. Permission may be requested for telephone follow-up (with the patient or physician)
of patients not seen regularly at NIH.
...
Status | Completed |
Enrollment | 3050 |
Est. completion date | September 11, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 100 Years |
Eligibility |
- INCLUSION CRITERIA: All patients greater than or equal to 12 months of age with tumors of the CNS of interest to the NOB, who may be candidates for another NOB trial at some point in the future. Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease. Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. Availability of a parent or legal guardian to give informed consent for children. EXCLUSION CRITERIA: Patients less than 12 months of age. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols. | Generalized knowledge about CNS Tumors | Ongoing |
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