Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00813566 : Multi-Tracer PET Assessment of Primary Brain Tumors
Phase
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

Three different adult patient groups will be eligible for inclusion in this study:

- Group 1: Adult patients with compelling evidence of primary brain tumor based on
clinical and MRI imaging characteristics that have not yet received surgery,
histological diagnosis, or any tumor-directed therapy. Such evidence will include: MRI
or CT scan-documented mass lesion within the brain, accompanied by anatomically
appropriate neurological signs and symptoms, in the absence of a probable competing
diagnosis such as brain abscess or primary intracranial hematoma.

- Group 2: Newly diagnosed primary malignant brain tumors (WHO Grade II - IV glial-based
tumors) who have not had a complete surgical resection and by contrast MRI have
residual tumor greater than 1.0 cm in diameter and will be receiving radiotherapy
and/or chemotherapy.

- Group 3: Patients with recurrent primary brain tumor as determined by standard
clinical criteria and MRI imaging.

- Patients must be 18 years or older for inclusion in this study. There is little
experience with the safety of [18F]FLT in children, and the risks associated with
radiation exposure may be increased for children under 18 years old as well.

- Karnofsky performance status > 60%.

- Patients must document their willingness to be followed for at least 24 months
after recruitment by signing informed consent documenting their agreement to have
clinical endpoints and the results of histopathologic tissue analysis (when
tissue becomes available from routine care) entered into a research database.

- All patients, or their legal guardians, must sign a written informed consent and
HIPAA authorization in accordance with institutional guidelines.

- Determination of pregnancy status: Female patients that are not postmenopausal or
surgically sterile will undergo a serum pregnancy test prior to each set of
multi-tracer PET scans. A negative test will be necessary for such patients to
undergo research PET imaging.

- Pre-treatment laboratory tests for patients receiving [18F]FLT must be performed
within 21 days prior to study entry. These must be less than 2.5 times below or
above the upper or lower limit range for the respective laboratory test for entry
into the study. In those instances where a baseline laboratory value is outside
of this range, then such a patient will be ineligible for enrollment. For the
followup scanning sessions after therapy has been instituted, laboratory testing
will also be required due to the use of FLT. The patients have brain tumors and
will receive various forms of therapy; therefore many routine laboratory tests
may not be within the typical normal range. As such, a factor of 4.0 times above
or below the upper or lower value for the normal range for any laboratory test
will be used to determine the acceptable range for the 2nd and possible 3rd
imaging timepoints. The baseline laboratory testing will include liver enzymes
(ALT, AST, ALK, LDH), bilirubin (total), serum electrolytes, CBC with platelets
and absolute neutrophil counts, prothrombin time, partial thromboplastin time,
BUN, creatinine. Previous urinalysis abnormalities will not preclude the patient
from being studied. For those patients receiving coumadin or another
anticoagulant the upper limit for prothrombin time or partial thromboplastin time
must not exceed 6 times the upper limit of the normal range.

Exclusion Criteria:

- Patients with clinically significant signs of uncal herniation, such as acute
pupillary enlargement, rapidly developing motor changes (over hours), or rapidly
decreasing level of consciousness, are not eligible.

- Patients with known allergic or hypersensitivity reactions to previously administered
radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune
diseases may be enrolled at the Investigator's discretion.

- Patients who are pregnant or lactating or who suspect they might be pregnant. Serum
pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female
patients that are not postmenopausal or surgically sterile.

- Adult patients who require monitored anesthesia for PET scanning.

- HIV positive patients due to the previous toxicity noted with FLT in this patient
group.

- Patients who have undergone surgery or receive any previous tumor-directed therapy for
their brain tumor.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00813566      |      Link to official Clinicaltrials.gov listing
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